Intercept - Phase 3 REGENERATE Study of Obeticholic Acid in Patients with Liver Fibrosis Due to NASH

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Healio

NASH update: 5 reports on trials, meetings, upcoming collaborations

February 19, 2019

The beginning of 2019 has already seen several significant advancements for the field of nonalcoholic steatohepatitis, from the inaugural NASH-TAG meeting to the recently announced positive results from the phase 3 study of Ocaliva.

Healio Gastroenterology and Liver Disease presents the following reports including trial results for Ocaliva (obeticholic acid, Intercept Pharma), a take-home report from NASH-TAG, and an update for this year’s International NASH Day.

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CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

NASH: Fastest-growing cause of liver cancer in transplant candidates

February 5, 2019

Nonalcoholic steatohepatitis may soon supplant chronic hepatitis C as the leading cause of hepatocellular carcinoma among patients awaiting liver transplantation, according to the findings of a national longitudinal registry study

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Press Release

Intercept Announces Positive Topline Results from Pivotal Phase 3 REGENERATE Study of Obeticholic Acid in Patients with Liver Fibrosis Due to NASH

First and largest successful pivotal Phase 3 study in patients with liver fibrosis due to NASH

OCA achieves primary endpoint demonstrating statistically significant improvement in liver fibrosis without worsening of NASH at 18 months (p=0.0002)

Intercept intends to file for regulatory approval in the U.S. and Europe in the second half of 2019

Results to be presented at European Association for the Study of the Liver 2019 International Liver Congress

The International Liver CongressTM
Every year in April, scientific and medical experts from a broad range of fields including hepatology, gastroenterology, internal medicine, cell biology, transplant surgery, infectious diseases, microbiology and virology, pharmacology, pathology and radiology and imaging come together from around the world to learn about the latest in liver research. Specialists share recent data, present studies and findings, and discuss the hottest topics on liver disease. The annual Congress attracts around 10,000 delegates and 250 media representatives from all over the world making this a truly international networking opportunity!

The International Liver CongressTM 2019 #ILC2019 will take place 10-14 April 2019 at the Reed Messe Wien Exhibition & Congress Center, Vienna, Austria.

Intercept Press Release
NEW YORK, Feb. 19, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced positive results from its pivotal Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH). In the primary efficacy analysis, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis (p=0.0002 vs. placebo). In the primary efficacy analysis, a numerically greater proportion of patients in both OCA treatment arms compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis, but this did not reach statistical significance. As agreed with the U.S. Food and Drug Administration (FDA), in order for the primary objective to be met, the study was required to achieve one of the two primary endpoints.

“We are thrilled to report the first positive registrational Phase 3 study results in patients with NASH, a devastating disease that is on track to become a leading cause of liver transplant in coming years,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “The topline REGENERATE data we are reporting today support our belief that OCA will become the first approved medicine for those living with liver fibrosis due to NASH. We are deeply grateful to the patients, investigators and study staff whose ongoing participation in REGENERATE has brought us one step closer to delivering a much-needed therapeutic option to address the enormous unmet medical need in this population.”

Based on these results, Intercept intends to file for approval in the U.S. and Europe in the second half of 2019. OCA remains the only investigational drug to have received Breakthrough Therapy designation from the FDA for NASH with fibrosis. REGENERATE results will be presented at the European Association for the Study of the Liver (EASL): The International Liver CongressTM 2019.

“Patients with significant fibrosis due to NASH are at the greatest risk of progression to severe liver-related complications, such as liver failure and death, and fibrosis is considered the strongest predictor of liver-related mortality in this population,” said Zobair M. Younossi, M.D., Professor and Chairman of the Department of Medicine at Inova Fairfax Medical Campus, Professor of Medicine at Virginia Commonwealth University, Inova Campus and the Chair of the REGENERATE Steering Committee. “I am very encouraged by these results that demonstrate OCA’s ability to significantly improve fibrosis in patients with advanced disease. As the first successful pivotal trial in NASH, REGENERATE is an important advancement for the liver community.”

Efficacy Results
The primary efficacy analysis (Intent-to-Treat or ITT) assessed efficacy at 18 months in 931 patients with stage 2 or 3 liver fibrosis due to NASH. Overall study discontinuations in the primary efficacy analysis population were balanced across treatment arms: 16% in placebo, 17% in OCA 10 mg and 15% in OCA 25 mg.

An additional pre-specified full efficacy analysis at 18 months added an exploratory cohort of 287 NASH patients with stage 1 liver fibrosis and additional risk factors who were at increased risk of progression to cirrhosis (N=1,218).

Patients with biopsy proven NASH with fibrosis were randomized 1:1:1 to receive placebo, OCA 10 mg or OCA 25 mg once daily. A repeat biopsy was conducted after 18 months for histologic endpoint assessment. Patients without a repeat biopsy due to study discontinuation or other reason were treated as non-responders in the primary and full efficacy analyses. 

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Fibrosis Improvement at Month 18

NASH Resolution at Month 18

Safety and Tolerability
The safety population in this planned 18-month analysis of REGENERATE included 1,968 randomized patients who received at least one dose of investigational product (OCA or placebo).

Adverse events were generally mild to moderate in severity and the most common were consistent with the known profile of OCA. The frequency of serious adverse events was similar across treatment arms (11% in placebo, 11% in OCA 10 mg and 14% in OCA 25 mg) and no serious adverse event occurred in >1% of patients in any treatment arm. There were 3 deaths in the study (2 in placebo: bone cancer and cardiac arrest, 1 in OCA 25 mg: glioblastoma) and none were considered related to treatment.

The most common adverse event reported was dose-related pruritus (19% in placebo, 28% in OCA 10 mg and 51% in OCA 25 mg). The large majority of pruritus events were mild to moderate, with severe pruritus occurring in a small number of patients (<1% in placebo, <1% in OCA 10 mg and 5% in OCA 25 mg). A higher incidence of pruritus associated treatment discontinuation was observed for OCA 25 mg (<1% in placebo, <1% in OCA 10 mg and 9% in OCA 25 mg). According to the clinical study protocol, investigator assessed severe pruritus mandated treatment discontinuation.

Consistent with observations from previous NASH studies, OCA treatment was associated with an increase in LDL cholesterol, with a peak increase of 22.6 mg/dL at 4 weeks and subsequently reversing and approaching baseline at month 18 (4.0 mg/dL increase from baseline). Triglycerides rapidly and continually decreased in the OCA treatment arms through month 18. There were few and varied serious cardiovascular events and incidence was balanced across the three treatment arms (2% in placebo, 1% in OCA 10 mg and 2% in OCA 25 mg).

With respect to hepatobiliary events, more patients (3%) on OCA 25 mg experienced gallstones or cholecystitis compared to <1% on placebo and 1% on OCA 10 mg. While numerically higher in the OCA 25 mg treatment arm, serious hepatic adverse events were uncommon with <1% incidence in each of the

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MarketWatch 

Intercept Pharmaceuticals is one step closer to getting FDA approval for the first-ever NASH drug

There are no approved treatments for NASH, or nonalcoholic steatohepatitis, a serious liver disease caused by fat accumulation in the liver that can result in chronic inflammation and scarring, or fibrosis. Eventually, the disease can lead to liver failure, cancer and death. 

Intercept’s treatment, obeticholic acid (OCA), is meant to treat patients with liver fibrosis due to NASH. The Phase 3 trial enrolled 931 patients with liver fibrosis who were randomly assigned to be treated with a placebo drug or one of two doses of OCA. 

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At JPM, the NASH flood gates start to crack

J.P. Morgan Healthcare Conference in San Francisco

At JPM, the NASH flood gates start to crack 
Jacob Bell

Four companies are within striking distance of filing NASH drugs for approval, but the competitive landscape is more nuanced than simply crossing the finish line first...

While JPM didn't bring data updates for the later-stage NASH pipeline, drugmakers did give more color on their mindset heading into such a pivotal year....

John McHutchison, Gilead's head of R&D, told investors at JPM he anticipates "waves of approval," with the first being highly potent treatments for patients who have more advanced fibrosis, and then subsequent waves that work on less severe NASH and have better safety profiles.....
Read the article:
https://www.biopharmadive.com/news/nash-2019-jpm-readouts-deals-market-competition/545772/

Articles available on this blog: Nonalcoholic Steatohepatitis (NASH)
Non-alcoholic Fatty Liver Disease (NAFLD)
Jan 11, 2019 - NASH update: 6 recent reports on treatment development 
Jan 9, 2019 - Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis 
After The Liver Meeting 2018 Summary: Viral Hepatitis & Fatty Liver Disease 

Gilead Presents Data From Nonalcoholic Steatohepatitis (NASH) Development Program for Advanced Fibrosis at The Liver Meeting® 2018
All current NASH & NAFLD blog posts:
Watch videos, or review research in this current collection of articles

NASH update: 6 recent reports on treatment development

Healio - Hepatology - Steatohepatitis/Metabolic Liver Disease 

NASH update: 6 recent reports on treatment development

Researchers continue efforts to study and develop safe and effective therapeutics to treat nonalcoholic fatty liver disease and its progressive form, nonalcoholic steatohepatitis, including several collaborative efforts between clinical development companies and societies.

Healio Gastroenterology and Liver Disease presents the following reports on recent NASH studies including data on a newly formed “NASH Roundtable,” positive results from recent clinical trials, and a new LiverMultiScan tool for identifying NASH....

Read more: https://www.healio.com/hepatology/steatohepatitis-metabolic-liver-disease/news/online/%7B8db09cf7-1eb0-4103-8b70-efab71f1d962%7D/nash-update-6-recent-reports-on-treatment-development

Gilead and Yuhan co-develop novel therapeutic candidates for Nonalcoholic Steatohepatitis (NASH)

Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis
Gilead Sciences and Yuhan Corporation Announce Collaboration and License Agreement to Develop Novel Investigational Treatments for Advanced Fibrosis Due to Nonalcoholic Steatohepatitis

FOSTER CITY, Calif. & SEOUL, Korea--(BUSINESS WIRE)--Jan. 6, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) and Yuhan Corporation (000100.KS; Yuhan) today announced that the companies have entered into a licensing and collaboration agreement to co-develop novel therapeutic candidates for the treatment of patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190106005116/en/

Under the agreement, Gilead will acquire global rights to develop and commercialize novel small molecules against two undisclosed targets in all countries, with the exception of the Republic of Korea where Yuhan will retain certain commercialization rights. Yuhan and Gilead will jointly conduct preclinical research, and Gilead will be responsible for global clinical development. Gilead will also be responsible for commercialization worldwide, outside of Yuhan’s rights in the Republic of Korea. In connection with this agreement, Yuhan will receive an upfront payment of $15 million and is eligible to receive up to an additional $770 million in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on future net sales. This agreement builds on the companies’ existing commercial collaboration to support the promotion of Gilead’s medicines in the Republic of Korea.

NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis due to NASH, defined as bridging fibrosis (F3) or cirrhosis (F4), may face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation, and are at a significantly higher risk of liver-related mortality. Currently, patients living with NASH have limited treatment options.

“This collaboration builds on our long-term partnership with Yuhan, with a new focus on the investigation of novel approaches to treat patients with advanced fibrosis due to NASH that complement our ongoing research programs,” said John McHutchison, MD, AO, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “We look forward to working with the Yuhan team to advance our work in this area where there is a significant unmet need for patients.”

“I am very pleased by this collaboration, which significantly expands and deepens our longstanding, trusted partnership with Gilead. We are confident that Gilead’s expertise in liver disease will accelerate the development of our novel agents. As a company, we are committed to investigating new therapeutics to improve the lives of patients with NASH,” said Mr. Jung Hee Lee, President and CEO of Yuhan.

HighTide Receives Fast Track Designation for new drug to treat NASH

[Rockville, Maryland, Nov. 27, 2018] — HighTide Therapeutics Inc., a clinical-stage biopharmaceutical company, announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with nonalcoholic steatohepatitis (NASH).

Liping Liu, PhD, Chief Executive Officer of HighTide, commented, “NASH represents a rapidly developing field with potential therapeutic options in the pipeline, yet none have made it to the market. At the recent AASLD Liver Meeting, experts in the field generally agreed that modest clinical responses to date are likely to be improved by thoughtful combination approaches. HTD1801, a multifunctional oral therapeutic, was designed to address the complex nature of NASH, especially for patients with comorbid diabetes and/or dyslipidemia. We are pleased by the FDA’s decision and look forward to bringing this much needed solution to millions of patients suffering from this disease.”

“This represents another step forward in our development of HTD1801 for the treatment of liver diseases with no currently approved therapies. We are proceeding with parallel clinical development of HTD1801 for NASH as well as primary sclerosing cholangitis (PSC) for which HTD1801 already received Orphan Drug Designation and Fast Track Designation,” said Janice Soreth, M.D., Chief Strategy and Regulatory Officer of HighTide, former Associate Commissioner for Special Medical Programs at the FDA.

FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An investigational drug that receives Fast Track Designation is eligible for more frequent communications between the FDA and the company relating to the development plan and clinical trial design, and may be eligible for priority review if certain criteria are met.

HighTide completed a first in human study of HTD1801 in healthy volunteers. A multi-center Phase 2 trial in adult patients with NASH is scheduled to enroll soon in the United States. A multi-center Phase 2 trial in adult patients with PSC is currently ongoing in the United States.

About HighTide Therapeutics and HTD1801
HighTide Therapeutics Inc., founded in 2011, is dedicated to the discovery and development of innovative therapeutics for people suffering from chronic liver diseases, gastrointestinal diseases and metabolic disorders with large and unsatisfied market needs.

HTD1801 is a new molecular entity being developed for the treatment of PSC and NASH.

About Nonalcoholic Steatohepatitis
Nonalcoholic steatohepatitis (NASH), a form of nonalcoholic fatty liver disease (NAFLD), is a chronic, complex liver disease characterized by hepatitis – inflammation of the liver – and liver cell damage, which can lead to fibrosis of the liver. NASH can lead to cirrhosis and liver cancer. Prevalence of NASH is on the rise and it may soon surpass hepatitis C as a cause for liver transplant. Currently, there are no approved therapies for NASH.

Gilead Presents Data From Nonalcoholic Steatohepatitis (NASH) Development Program for Advanced Fibrosis at The Liver Meeting® 2018

Meeting Coverage @ Healio

Nov 27, 2018

VIDEO: Gilead reports phase 2 safety, efficacy of GS-9674 for NASH

SAN FRANCISCO — In this exclusive video perspective from The Liver Meeting 2018, Rob Myers, MD, senior director of the liver diseases therapeutic area at Gilead…

View all updates on this blog (LINK), recommended coverage elsewhere (LINK). 

Gilead Press Release

November 09, 2018

Gilead Presents Data From Nonalcoholic Steatohepatitis (NASH) Development Program for Advanced Fibrosis at The Liver Meeting® 2018

-- Phase 2 Data Presented on Investigational FXR Agonist GS-9674 in NASH --
-- Enrollment Complete in Phase 2 ATLAS Combination Trial of Three Investigational Therapies Targeting Distinct Mechanisms of the Disease --

SAN FRANCISCO--(BUSINESS WIRE)--Nov. 9, 2018-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the company’s clinical development program for advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Data presented support the ongoing development of the company’s investigational compounds, evaluate the utility of noninvasive tests for the identification of patients with advanced fibrosis, and demonstrate the significant burden of disease in affected patients. The data presented across 24 abstracts are being shared at The Liver Meeting® 2018 in San Francisco this week.

Data from a Phase 2 randomized, placebo-controlled trial of the investigational, selective, non-steroidal farnesoid X receptor (FXR) agonist GS-9674 will be presented. In this study, 140 NASH patients were treated with GS-9674 100 mg, GS-9674 30 mg or placebo orally once daily for 24 weeks. A decline of at least 30 percent in hepatic fat measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) was observed in 38.9 percent of patients treated with GS-9674 100 mg (p=0.011 vs placebo), 14 percent treated with GS-9674 30 mg (p=0.87), and 12.5 percent with placebo. Improvements in liver biochemistry tests (serum GGT) and markers of reduced bile acid synthesis (serum C4 and bile acids) were observed in the 30 mg and 100 mg arms of GS-9674-treated patients.

GS-9674 was generally well tolerated; moderate to severe pruritus, or itching, occurred in 14 percent of patients in the GS-9674 100 mg arm compared to four percent in the GS-9674 30 mg and placebo arms. Changes in lipid profile and glycemic parameters did not differ between GS-9674 and placebo-treated patients. The most common adverse events in patients treated with GS-9674 were pruritus, upper respiratory tract infection, headache and fatigue. Treatment was discontinued due to adverse events in one patient treated with GS-9674 100 mg (two percent), five patients treated with GS-9674 30 mg (nine percent), and two patients with placebo (seven percent).

A separate Phase 2 study (ATLAS) is investigating treatment with GS-9674, the investigational apoptosis signal-regulating kinase 1 (ASK-1) inhibitor selonsertib, and the investigational acetyl-CoA carboxylase (ACC) inhibitor GS-0976 alone or in combination, in patients with advanced fibrosis due to NASH. This randomized, double-blind 52-week study will assess improvement in fibrosis without worsening of NASH, adverse events and laboratory abnormalities in approximately 350 patients.

“We believe our development program is well positioned to address the unmet need for effective therapies for people living with advanced fibrosis due to NASH. We are pleased to share that the Phase 2 ATLAS combination trial of experimental GS-9674, selonsertib, and GS-0976 has completed enrollment ahead of schedule,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “We also continue to support the liver community in the study of noninvasive tests to help overcome the risks and limitations of liver biopsies in the diagnosis of advanced fibrosis due to NASH.”

Noninvasive Tests
In a late-breaker session, Gilead will present an analysis of baseline data from its Phase 3 STELLAR trials of selonsertib suggesting that the use of currently available noninvasive tests (NITs) can accurately identify patients with advanced fibrosis (F3-F4) due to NASH and potentially reduce the need for liver biopsy. The use of the Fibrosis-4 (FIB-4) index, Enhanced Liver Fibrosis (ELF) test and liver stiffness measurement by FibroScan® (FS) each demonstrated good sensitivity and specificity for the discrimination of advanced fibrosis due to NASH when compared to liver biopsy. When used sequentially, FIB-4 followed by FS or the ELF test accurately identified advanced fibrosis in 76-81 percent of patients while reducing the frequency of indeterminate results to as low as 13 percent.

“There is a major need for accurate and readily available tests to diagnose patients with advanced fibrosis due to NASH, a disease which affects many aspects of patients’ lives,” said Zobair Younossi, MD, MPH, FACP, FACG, AGAF, FAASLD, lead study author and Chairman and Professor, Department of Medicine, Inova Fairfax Hospital. “These findings from the STELLAR program indicate that currently available noninvasive tools, when used alone or sequentially, can identify these patients with advanced fibrosis due to NASH rather accurately, providing a potentially simple option for physicians to use in clinical practice.

Burden of Disease
Baseline data from patients enrolled in the STELLAR Phase 3 program presented in a poster session at The Liver Meeting® 2018 demonstrate the significant burden of disease among people with advanced fibrosis due to NASH. In 1,660 patients enrolled in the STELLAR trials, patient-reported outcome measures (PROs) were assessed prior to treatment initiation and compared with population norms. The data demonstrate that physical health-related PRO scores of NASH patients were significantly lower than population norms. In addition, patients with cirrhosis had lower PRO scores than those with bridging fibrosis in areas including bodily pain, social functioning, and all but one domain of the disease-specific Chronic Liver Disease Questionnaire (CLDQ) for nonalcoholic fatty liver disease (NAFLD) and NASH.

In another analysis of patients enrolled in the STELLAR Phase 3 study presented during a poster session, elevated values of the ELF test and NAFLD fibrosis score were associated with impairment in PROs, especially physical health-related scores and the scores captured by the disease-specific CLDQ-NAFLD/NASH. These data extend prior observations that noninvasive fibrosis markers may predict fibrosis stage and adverse clinical outcomes, and now, impairments in health-related quality of life, in patients with NASH.

GS-9674, selonsertib and GS-0976 are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Their safety and efficacy have not been established.

About Gilead’s Clinical Programs in NASH
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis, defined as bridging fibrosis (F3) or cirrhosis (F4), are at a significantly higher risk of liver-related mortality.

Gilead is advancing multiple novel investigational compounds for the treatment of advanced fibrosis due to NASH, evaluating single-agent and combination therapy approaches against the core pathways associated with NASH – hepatocyte lipotoxicity, inflammation and fibrosis. Investigational compounds in development include the ASK1 inhibitor selonsertib, the selective, non-steroidal FXR agonist GS-9674 and the ACC inhibitor GS-0976. The STELLAR Phase 3 trial program evaluating selonsertib among NASH patients with bridging fibrosis (F3) or cirrhosis (F4) is ongoing. GS-9674 and GS-0976 are currently in Phase 2 studies in NASH.
http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2376502

The Liver Meeting: Gilead making gains in NASH, PSC programs

New data from two mid-stage studies of Gilead Sciences Inc.'s farnesoid X receptor agonist (FXR) reported during the American Association for the Study of Liver Diseases meeting showcased the company's ongoing efforts to establish new strengths beyond viral hepatitis C, where time and competition have eroded its dominance. Though still active on the next frontier of the hepatitis battle, HBV, most of the company's liver disease pipeline today is focused on nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and primary biliary cirrhosis (PBC).

Liver Meeting® 2018 - Conatus Pharmaceuticals Announces Presentations and Posters

Liver Meeting® - Conatus Pharmaceuticals Announces Presentations and Posters

SAN DIEGO, Nov. 08, 2018 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) announced today the schedule of upcoming oral presentations and posters addressing clinical and preclinical results with the company’s pan-caspase inhibitor emricasan, or addressing preclinical results with the company’s pan-caspase inhibitor IDN-7314, at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco November 9-13, 2018.

Poster #1226, “Multicenter, double-blind, randomized trial of emricasan in subjects post liver transplantation (LT) with recurrent hepatitis C virus (HCV) and liver fibrosis or cirrhosis despite achieving sustained virologic response (SVR),” will be displayed by Catherine Frenette, M.D., (Scripps Clinic, La Jolla, CA) in the Liver Transplantation: Viral Hepatitis section on Saturday, November 10, from 2:00 p.m. to 7:30 p.m. PT, in the Moscone Center Poster Hall – Hall C.

Presentation #251A, highlighting selected content from poster #1226, will be delivered by K. Rajinder Reddy, M.D., (University of Pennsylvania Medical Center, Philadelphia, PA) in the Parallel 37: Liver Transplantation: Alcohol and Hepatitis C session on Monday, November 12, at 3:15 p.m. PT, in the Moscone Center Room 153/155.

Presentation #25, “Intestinal dysbiosis augments liver disease progression via NLRP3 in a murine model of primary sclerosing cholangitis,” will be delivered by Kai M. Schneider (Department of Internal Medicine III, University Hospital RWTH Aachen, Aachen, Germany) in the Presidential Plenary Session on Translational Science and Genomics on Tuesday, November 13, 9:00 a.m. PT., in the Moscone Center General Session – Hall D.

Poster #1344, “Molecular mechanisms underlying the effects of emricasan in portal hypertension and chronic liver disease: the hepato-sinusoidal cross-talk matters,” will be displayed by Jordi Gracia-Sancho, Ph.D., (Idibaps Biomedical Research Institute, Ciberehd, Barcelona, Spain; Hepatology, Inselspital, Bern, Switzerland; and Barcelona Liver Services) in the Portal Hypertension and Other Complications of Cirrhosis: Experimental section on Saturday, November 10, from 2:00 p.m. to 7:30 p.m. PT, in the Moscone Center Poster Hall – Hall C.

“With three ongoing ENCORE Phase 2b clinical trials evaluating emricasan in patients with nonalcoholic steatohepatitis (NASH), all with top-line results expected over the next nine months, we are encouraged by the preclinical and clinical data being featured at the AASLD meeting demonstrating the activity and effects of pan-caspase inhibitors,” said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D. “We thank our principal investigators and our scientific collaborators for their continued efforts to better understand and apply the multiple mechanistic effects of caspase inhibitors on liver structure and function, driving their disease-modifying potential. We are pleased with the opportunity to share their latest findings at the AASLD meeting, and we look forward to sharing results from the ENCORE trials.”
www.conatuspharma.com.

Liver Meeting® 2018- Exalenz to Present Positive Clinical Data for Breath ID® in NASH cirrhosis patients

Exalenz to Present Positive Clinical Data for the Breath ID® 13C-Methacetin Breath Test System at the Liver Meeting® 2018

MODI’IN, Israel and MANASQUAN, N.J., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Exalenz Bioscience Ltd. (TASE: EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced that the Company will present positive data from a Phase 2 trial, conducted by Galectin Therapeutics in NASH cirrhosis patients (ie the NASH-CX trial), utilizing its BreathID® 13C-Methacetin Breath Test (MBT) System in patients with compensated non-alcoholic steatohepatitis (NASH).

The poster presentation is titled “The Noninvasive Point of Care MBT Accurately Predicts Decompensation Events Better Than MELD in Compensated (MELD <15) Nash Cirrhotics” (#1337) will be presented at the Liver Meeting® 2018 on November 10 at 2:00 PM PT / 5:00 PM ET. The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), is being held November 9 - 13, 2018 in San Francisco. The lead author is Naga Chalasani, MD, Associate Dean for Clinical Research and a Professor of Medicine at the Indiana University School of Medicine.

“Results of this study indicate that the MBT has the potential to predict liver decompensation in patients with compensated NASH cirrhosis, which may enable earlier intervention and improved management of these patients,” said Raffi Werner, Chief Executive Officer of Exalenz Bioscience. “We believe that these results add to the growing body of data supporting the MBT as an important alternative to more invasive detection methods and support our strategy to advance this innovative test to the market, potentially launching the product in 2020.”

About MBT
MBT is a simple, noninvasive Point of Care breath-based test in which a patient drinks a half glass of a tasteless solution that is metabolized exclusively in the liver. The patient’s exhaled breath is automatically collected and assayed with the BreathID® system to measure the amount of a specific breakdown product of the solution, which reflects the rate of liver metabolism.

In addition to evaluating MBT to monitor NASH patients, it is also being developed to detect CSPH in the advanced NASH patient population, as well as in monitoring patients with confirmed diagnoses of acute liver failure (ALF). The ability to monitor patients with a simple, noninvasive test has the potential to radically improve the management and outcomes of patients with an array of liver diseases.

About NASH

More than 8 million people in the United States and Europe are living with advanced non-alcoholic steatohepatitis (NASH), the most severe form of non-alcoholic fatty liver disease (NAFLD) and a major risk factor for liver transplant and the development of primary liver cancer. The incidence of NAFLD is expected to increase more than 21% by 2030, with a concomitant increase of more than 63% in the incidence of NASH in the same period.

https://globenewswire.com/news-release/2018/11/05/1644726/0/en/Exalenz-to-Present-Positive-Clinical-Data-for-the-Breath-ID-13C-Methacetin-Breath-Test-System-at-the-Liver-Meeting-2018.html

Liver Meeting® 2018 - Intercept's NASH clinical development program

Intercept Announces New OCA Data to be Presented at The Liver Meeting® 2018

NEW YORK, Nov. 05, 2018 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that multiple obeticholic acid (OCA) abstracts will be presented at The Liver Meeting® 2018, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 9-13 in San Francisco, California.

“At this year’s Liver Meeting, we look forward to sharing new data from our innovative clinical programs, which further our understanding of treatment approaches aimed at impacting the lives of patients with progressive non-viral liver diseases,” said Christian Weyer, M.D., M.A.S., Intercept's Executive Vice President, Research & Development. “As we approach the read-out from the interim analysis of our Phase 3 REGENERATE trial in the first half of 2019, we are excited to present abstracts that highlight the depth and breadth of our NASH clinical development program.”

Select presentations at The Liver Meeting include:
Oral Presentation:
Sunday, November 11, 2018 – 11:30 a.m. PT
“Obeticholic Acid Was Safe and Well Tolerated in Patients with NASH and Compensated Cirrhosis: A Secondary Analysis of the CONTROL Study” (Abstract #0071)
Dina Halegoua-DeMarzio, Paul Thuluvath, Manal F. Abdelmalek, Courtney Van Biene, Reshma Shringarpure, Leigh MacConell

Poster Presentations:
Sunday, November 11, 2018 – 8 a.m. – 5:30 p.m. PT
“CONTROL: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Patients with Nonalcoholic Steatohepatitis” (Abstract #1672)
Paul J. Pockros, Michael Fuchs, Bradley Freilich, Eugene Schiff, Anita Kohli, Eric J. Lawitz, Paul A. Hellstern, David E. Cohen, Janet Owens-Grillo, Courtney Van Biene, Reshma Shringarpure, Leigh MacConell, David Shapiro

“Efficacy and Safety of Obeticholic Acid in Patients with Nonalcoholic Steatohepatitis and Significant Fibrosis Using Endpoint Definitions and Populations Accepted for Registrational Studies” (Abstract #1673)
Brent A. Neuschwander-Tetri, Kris V. Kowdley, Arun J. Sanyal, Manal F. Abdelmalek, Norah Terrault, Arthur J. McCullough, Peter Wang, Reshma Shringarpure, Leigh MacConell, David A. Shapiro, Rohit Loomba

“Safety, Pharmacokinetics and Pharmacodynamics of Obeticholic Acid in Subjects with Compensated Cirrhosis due to NASH” (Abstract #1709)
Naim Alkhouri, Jeffrey Edwards, Fred Poordad, Eric Lawitz, Lois Lee, Sharon Karan, Jason Campagna, Leigh MacConell

“Beyond Sirius Red: Collagen Isoforms for Quantitative Histological Analysis of Liver Fibrosis in Preclinical Models of Diet-induced and Biopsy-confirmed Nonalcoholic Steatohepatitis” (Abstract #1760)
Thea Johansen, Denise Oró, Sanne S. Veidal, Michael Feigh, Henrik H. Hansen, Niels Vrang, Mark Young, Jacob Jelsing, Jonathan D. Roth

Monday, November 12, 2018 – 8 a.m. – 5:30 p.m. PT
“Hepatic Safety Overview of Obeticholic Acid for the Treatment of Patients with Primary Biliary Cholangitis” (Abstract #1931)
Paul J. Pockros, Mitchell L. Shiffman, Christopher Bowlus, Arun J. Sanyal, Frederik Nevens, Richard Pencek, David Shapiro, Amrik Shah, Leigh MacConell

“PBC Patient Care Pathway” (Abstract #1886)
Gideon M. Hirschfield, Marco Carbone, Helena Cortez-Pinto, Guilherme Macedo, Victor de Lédinghen, Olivier Chazouilleres, Femi Adekunle

“Characterization of Primary Biliary Cholangitis (PBC) in Canadian Patients” (Abstract #1916)
Eric Yoshida, Robert Bailey, Magdy Elkhashab, Dusanka Grbic, Nir Hilzenrat, Euiseok Kim, Gerald Minuk, Meaghan O'Brien, Kevork Peltekian, Marco Puglia, Alnoor Ramji, Mark Swain, Edward Tam, Cynthia Tsien, Catherine Vincent, Vlad Popovic, Jamie Twiselton, Belinda Yap

A full list of sessions at The Liver Meeting is available on the AASLD website at: www.aasld.org/events-professional-development/liver-meeting.

Cirius Therapeutics Reports On Phase 2b Trial in NASH Patients with Fibrosis

Cirius Therapeutics Reports Positive Data for MSDC-0602K in Interim Analysis of Phase 2b Clinical Trial in NASH Patients with Fibrosis

- Interim analysis showed statistically significant reductions in liver enzymes, including ALT and AST, measured from baseline at six months

- In two highest dose groups, at least 50% of patients with high baseline ALT or AST improved to normal range at six months

- Statistically significant reductions in HbA1c and other measures of glycemic control and insulin resistance were observed

- Overall adverse event rate was similar across placebo and all doses of MSDC-0602K

- Largest Phase2b clinical trial including paired biopsies conducted in NASH; biopsy data after 12 months of treatment expected to be reported in the second half of 2019

SAN DIEGO and KALAMAZOO, Mich., Oct. 25, 2018 /PRNewswire/ -- Cirius Therapeutics today announced positive results from an interim analysis of exploratory endpoints from its ongoing, fully enrolled Phase 2b clinical trial (the EMMINENCE trial) evaluating MSDC-0602K in 402 patients diagnosed with non-alcoholic steatohepatitis (NASH) with fibrosis. The interim analysis, which was conducted in the first 328 patients to reach their six-month follow-up visit, showed that patients treated with MSDC-0602K had significant improvements from baseline in measures of liver function and insulin resistance at six months. MSDC-0602K, a second-generation insulin sensitizer, is designed to selectively modulate the mitochondrial pyruvate carrier (MPC), which at the cellular level mediates the effects of overnutrition, a major cause of NASH and other metabolic disorders.

The subjects included in this interim analysis had significant liver disease, as established by liver biopsy, with an average non-alcoholic fatty liver disease (NAFLD) activity score at baseline of 5.3. Almost sixty percent of these subjects had a baseline fibrosis score of 2 or 3 and approximately fifty percent also had a diagnosis of Type 2 diabetes at baseline. Overall, baseline characteristics were well-balanced across treatment groups.

Key findings from the interim analysis include improvements in liver enzymes, with placebo-corrected reductions at 6 months of 14.3 U/L (p<0.001) and 7.9 U/L (p=0.012) in ALT and AST, respectively, in the 125mg cohort, and 10.6 U/L (p=0.004) and 4.0 (NS) in ALT and AST, respectively, in the 250mg cohort. Placebo-corrected reductions, relative to baseline, were 25% and 18% in ALT and AST, respectively, in the 125mg cohort, and 19% and 9% in ALT and AST, respectively, in the 250mg cohort. Importantly, normalization of hepatic enzymes was observed across all three dose levels of MSDC-0602K. 

Percentage of patients with high baseline values who returned to normal range
	Placebo	62.5mg	125mg	250mg
ALT	15%	29%	60%	56%
AST	20%	36%	50%	52%

*ALT normal range defined as 6-34 U/L and 6-43 U/L for women and men, respectively; AST normal range defined as 9-34 U/L and 11-36 U/L for women and men, respectively) 

"We believe these interim results around improved measures of liver function and glycemic control, together with the preliminary adverse event profile, support MSDC-0602K's potential to be used in the treatment of NASH with fibrosis, including for those patients with Type 2 diabetes, a group which represents approximately 50% of patients with NASH," said Cirius' chief medical officer Howard Dittrich, M.D. "These results support the view that therapies directed toward the MPC have the potential to achieve insulin sensitizing pharmacology with an improved profile over first generation insulin sensitizers. We look forward to presenting full data to the scientific community." 

In addition to the improvement in ALT and AST, observations included significant improvement at six months in fasting glucose, HbA1c, insulin levels and HOMA-IR at the 125mg and 250mg dose levels.  Significant improvement in HbA1c was also observed in subjects with a diagnosis of Type 2 diabetes in the 125mg and 250mg cohorts.  

In this interim analysis, the overall rate of treatment emergent adverse events was similar across placebo and all MSDC-0602K cohorts. There was a higher rate of treatment emergent adverse events reported in the 250mg dose compared to placebo in the musculoskeletal and connective tissue disorders category. Within this category, arthralgia and back pain were the most frequently reported individual adverse events across the pooled 328 subjects. A modest dose-dependent increase in body weight was seen in MSDC-0602K treated subjects, a finding seen with insulin and with other therapies that seek to improve insulin resistance. The rate of peripheral edema observed at six months was similar to that observed at baseline and was comparable across placebo and all MSDC-0602K cohorts. 

"The interim results from the EMMINENCE trial, the largest Phase 2b clinical trial to include paired biopsies ever conducted in NASH, are compelling," said Stephen Harrison, M.D., the principal investigator in the EMMINENCE trial. "The improvements in hepatic enzymes observed to date are impressive, especially when combined with the meaningful improvements in glycemic control." 

About the EMMINENCE Trial

The EMMINENCE trial is a 12-month, randomized, double-blind, placebo-controlled trial evaluating three oral dose levels of MSDC-0602K. Endpoints of the clinical trial include hepatic histological changes measured by biopsy after 12 months of treatment, changes in liver and metabolic function measured by the liver enzymes ALT and AST, markers of liver fibrosis, glycemic control and safety and tolerability. Not all of these endpoints were examined in this interim analysis; rather, in addition to the safety variables of incidence of treatment-emergent adverse events and  peripheral edema grades, changes from baseline relative to placebo for a number of endpoints, including liver functions tests such as ALT and AST, among others, biomarkers and indirect measures of apoptosis and fibrosis, circulating inflammatory markers and markers of bone metabolism, serum triglycerides and fasting cholesterol, markers of insulin sensitivity, and blood pressure, were examined in an exploratory manner. 

About Cirius Therapeutics

Cirius is a clinical-stage pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and metabolic diseases. Our lead product candidate, MSDC- 0602K, is a novel small molecule being developed as a once-daily oral therapy to treat NASH with fibrosis. MSDC-0602K is designed to selectively modulate the MPC, which mediates at the cellular level the effects of overnutrition, a major cause of NASH and other metabolic disorders. We are conducting a Phase 2b clinical trial of MSDC-0602K, which we have fully enrolled with 402 patients diagnosed with NASH with fibrosis. We expect to report final data from this clinical trial in the second half of 2019.

SOURCE Cirius Therapeutics

The Liver Meeting®2018 - GENFIT: New data to be presented ahead of key results expected in 2018 and 2019

GENFIT: New data to be presented at 2018 AASLD meeting, ahead of key results expected in 2018 and 2019

KOL event to be held ahead of expected data release with elafibranor in PBC by end of 2018 (Phase 2) and in NASH end of 2019 (Phase 3)

Confirmation of the diagnostic performance of NIS4 algorithm in identifying NASH patients eligible to therapeutic intervention

Elafibranor’s potential as cornerstone drug in combination therapies for NASH confirmed with new data

New data indicating elafibranor’s potential in treating hepatic cancer (HCC)

Bioinformatics approaches based on deep learning methods paving the way for automatization of histological NASH diagnosis

Lille (France), Cambridge (Massachusetts, United States), October 2, 2018 – GENFIT (Euronext: GNFT – ISIN: FR0004163111), is a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases today announces its participation in The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 9-13, 2018. Abstracts are available on the meeting’s website. The Liver Meeting® is one of the most important congresses organized for the medical and scientific community specializing in hepatology worldwide. It brings together more than 10,000 scientists, gastroenterologists and hepatologists.

Update on NASH landscape
The 2018 edition of AASLD comes after the recent publication of a number of early-stage clinical study results, and importantly ahead of 2019, expected to bring significant catalysts in the NASH space. To date, only three programs globally have finalized the enrollment of their Phase 3 cohorts in NASH (Subpart H), paving the way for first late stage data readouts in 2019. GENFIT’s elafibranor is one of the aforementioned programs having the potential to be part of a first set of marketing approvals to offer clinicians the first therapeutic solutions for treating NASH (other molecules may follow only a few years later). It is also ideally positioned to potentially cover the widest spectrum of NASH patients, based on compelling Phase 2 data (Ratziu et al., Gastroenterology, 2016) that have shown elafibranor’s potential to combine:
Efficacy on “NASH resolution without worsening of fibrosis” (26% vs 5%; p-value 0,02), the biopsy-based regulatory endpoint for market approval that addresses the underlying cause of disease progression;
Beneficial cardiovascular profile (LDL, TG, HDL, insulin resistance), known to be crucial for NASH patients;
Clean safety and tolerability, essential for a chronic and silent condition like NASH.

Ahead of next year’s data readout in NASH with elafibranor, GENFIT is expected to make several announcements over the next few months in the field of PBC, NASH and fibrosis:
Elafibranor Phase 2 data readout in PBC by year end 2018;
Launch of a Phase 2 proof of concept study of nitazoxanide in NASH fibrosis;
Enrollment of the first pediatric NASH patient: elafibranor is the first and only molecule to be evaluated in pediatric NASH after having shown safety and efficacy in a Phase 2 trial on adult NASH patients;
Regulatory and commercial development milestones of the In Vitro Diagnostic test aimed at identifying NASH patients to be considered for treatment.

Events during AASLD
Prior to the new Phase 2 clinical data for elafibranor in PBC by year end 2018, GENFIT will hold a NASH/PBC KOL Meeting during AASLD, providing financial analysts and institutional investors a unique opportunity to understand how medical and scientific opinion leaders approach the challenges posed by these diseases and how they evaluate the potential of diagnostic and therapeutic solutions currently under development.

GENFIT will continue to engage with key stakeholders in order to move forward with the set up of its first Market Access Advisory Board that will be held in January next year. Early payer research already points to the strong differentiation of elafibranor.

Following the success of the 1st International NASH Day, GENFIT will host the first steering committee aimed at preparing the 2019 edition. It will be organized together with learned societies and patients associations who are expected to play an increasingly important leadership role. Feedback from the satisfaction survey run over the summer will help further increase the scale of the next edition.

From November 10 to 12, GENFIT will be present at the “Moscone North and South Convention Center” exhibition hall, allowing all scientific and medical staff attending the event to keep informed on the ongoing R&D programs. The institutional booth #635 and The NASH Education Program booth #244 will welcome meeting attendees.

New data presented during the Liver Meeting:
NASH Diagnostic: oral presentation, Sunday, November 11

The NIS-4 algorithm – non-invasive score combining circulating levels of miR-34a, Alpha2-macroglobulin, YKL-40 and HBA1c – is confirmed as a powerful NASH diagnostic tool to identify patients with active NASH (NAS>=4) and significant fibrosis (F>=2) irrespective of patient sex, age, obesity or type of diabetes.

“NIS4 for the detection of active NASH (NAS>=4) and significant fibrosis (F>=2) in 714 patients at risk of NASH: diagnostic metrics are not affected by age, sex, presence of type 2 diabetes or obesity”, R. Hanf et al. (Abstract 142)
Treatment with elafibranor: “Poster of distinction” and poster, Friday, November 9

New anti-NASH treatment combinations, using elafibranor – “first-in-class” PPAR alpha and delta receptor agonist – as backbone, were studied in in vitro and in vivo NASH models, associating it with an acetyl-CoA carboxylase inhibitor. A complementary and synergistic action was observed on fatty acid catabolism accompanied by resolution of liver steatosis. In addition, elafibranor counteracted the ACC inhibitor-induced hypertrigliceridemia.

“Elafibranor synergizes with ACC inhibitors to enhance fatty acid catabolism and reduce steatosis in the liver of a NASH model”, V. Legry et al. (Abstract 732)

As NASH is projected to become the most common risk factor for HCC, this in vivo study has shown that preneoplastic lesion development was prevented to a significant extent upon elafibranor treatment in rodent model. In addition, elafibranor directly reduced tumor cell proliferation.

“Elafibranor administration prevents liver tumor development in mouse models of NASH”, P. Parroche et al. (Abstract 737)
NASH diagnosis through deep learning: Poster, Saturday, November 10

The study has shown that scoring systems based on deep-learning methods showed similar results as with human evaluation which could facilitate the analysis of preclinical and, in the future, clinical NASH patients’ biopsies. GENFIT’s technology could also assist experts in better interpreting certain specific regions of cells in histological samples that are difficult to interpret.

“A rapid and reproducible quantification of ballooning and inflammation using a deep-learning approach and comparison with manual scoring”, E. Perspicace et al. (Abstract 1298)

About elafibranor
Elafibranor is GENFIT’s lead pipeline product. Elafibranor is an oral once-daily treatment, and a first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH) and Primary Biliary Cholangitis (PBC). Elafibranor is believed to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers. Elafibranor also presents a particularly interesting profile to potentially treat PBC, a rare liver disease.

About NASH
“NASH”, or nonalcoholic steatohepatitis, is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer.

About PBC
“PBC”, or Primary Biliary Cholangitis, is a chronic disease in which bile ducts in the liver are gradually destroyed. The damage to bile ducts can inhibit the liver’s ability to rid the body of toxins, and can lead to scarring of liver tissue known as cirrhosis.

About GENFIT
GENFIT is a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases. GENFIT’s concentrates its R&D efforts in areas of high unmet medical needs corresponding to a lack of approved treatments. GENFIT’s lead proprietary compound, elafibranor, is a drug candidate currently being evaluated in one of the most advanced Phase 3 studies worldwide (“RESOLVE-IT”) in nonalcoholic steatohepatitis (NASH), considered by regulatory authorities as a medical emergency because it is silent, with potentially severe consequences, and with a prevalence on the rise. It is also evaluated in a Phase 2 study in Primary Biliary Cholangitis (PBC), a rare liver disease. As part of its comprehensive approach to clinical management of NASH patients, GENFIT is conducting an ambitious discovery and development program aimed at providing patients and physicians with a blood-based test for the diagnosis of NASH, i.e. non-invasive and easy-to-access. With facilities in Lille and Paris, France, and Cambridge, MA (USA), the Company has approximately 130 employees. GENFIT is a public company listed in compartment B of Euronext’s regulated market in Paris (Euronext: GNFT – ISIN: FR0004163111). www.genfit.com

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