Showing posts with label AASLD 2018 The Liver Meeting®. Show all posts
Showing posts with label AASLD 2018 The Liver Meeting®. Show all posts

Thursday, October 11, 2018

Gilead to Present 50 Abstracts Across NASH, PSC, HBV and HCV at The Liver Meeting® 2018

Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018

PDF Download

-- More Than 50 Abstracts Across NASH, PSC, HBV and HCV Reflect Ongoing Commitment to Advancing the Care of People with Liver Disease--

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 11, 2018-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that data from the company’s liver disease research and development programs in nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infection will be presented at The Liver Meeting® 2018 in San Francisco from November 9-13, 2018. The data reflect Gilead’s ongoing commitment to advancing the care of patients with serious liver diseases.

“Gilead has transformed the treatment of viral liver diseases with innovative medicines that have cured HCV and significantly improved treatment of HBV for millions around the world,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research & Development, Gilead Sciences. “Today, we are working to bring this expertise and commitment to other serious liver diseases with significant unmet medical needs, such as advanced fibrosis due to NASH and PSC – two diseases with no or limited treatment options.”

Advanced Fibrosis due to NASH
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 investigational compounds for the treatment of advanced fibrosis due to NASH. Data being presented at the meeting further elucidate the potential role and safety profile of three compounds in development.

The non-steroidal FXR agonist GS-9674 leads to significant reductions in hepatic steatosis, serum bile acids, and liver biochemistry in a Phase 2, randomized, placebo-controlled trial of patients with NASH (poster #0736)
Hepatic metabolomics and plasma microRNA analysis of combinations of an ASK1 inhibitor, an ACC inhibitor, and an FXR agonist in the rat choline-deficient high fat diet model reveal reductions in oxidative stress, inflammation and fibrosis (poster #1265)

Currently, liver biopsy is the standard method to diagnose advanced fibrosis due to NASH. This invasive and costly procedure presents challenges to appropriate diagnosis and treatment. Data being presented at The Liver Meeting describe the potential role and sequence of noninvasive tests in the diagnosis of advanced fibrosis due to NASH and patient-reported outcomes from two global Phase 3 trials evaluating the investigational ASK1 inhibitor selonsertib.

Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data from STELLAR clinical trials (late-breaking poster #LB-10)
Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib (poster #1674)
Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to NASH (poster #1683)
Advanced fibrosis based on noninvasive tests in NASH is associated with impairment of patient-reported outcomes (poster #1991)

PSC
Data will be presented from a Phase 2 trial evaluating the investigational non-steroidal farnesoid X receptor (FXR) agonist GS-9674 in PSC. PSC is a rare and chronic condition that causes inflammation and scarring of the bile ducts, which can lead to liver failure. There are limited treatment options currently available for patients with PSC.

The non-steroidal FXR agonist GS-9674 improves liver biochemistry and decreases serum bile acids in patients with PSC: A Phase 2, randomized, placebo-controlled trial (oral presentation #0043)

HBV Functional Cure
Data will also be presented from Gilead’s ongoing program directed at achieving a functional cure for HBV by maintaining viral suppression without ongoing therapy. GS-9688, an investigational oral selective toll-like receptor 8 (TLR8) agonist, is the subject of several studies to be presented, including first-in-human clinical results and Phase 1b results from evaluation in patients with chronic hepatitis B. 

First in human study of GS-9688, an oral Toll-like Receptor 8 (TLR8) agonist, in healthy volunteers: assessment of safety, tolerability, pharmacokinetics, pharmacodynamics and food effect (poster #0390)
Pharmacodynamic response to oral administration of the selective toll-like receptor 8 agonist GS-9688 in healthy volunteers (poster #0456)
Safety, pharmacokinetics and pharmacodynamics of oral TLR8 agonist GS-9688 in patients with chronic hepatitis B: a randomized, placebo-controlled, double-blind Phase 1b study (poster #0401)

GS-9674, selonsertib and GS-9688 are investigational compounds and are not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Their safety and efficacy have not been established.

Viral Hepatitis Treatment
Viral hepatitis presentations include studies of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in difficult to cure HCV populations and data demonstrating the role of Vemlidy® (tenofovir alafenamide 25mg, TAF) in the management of chronic hepatitis B.

Sofosbuvir/velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis (late-breaking poster #LB-15)
Ledipasvir/sofosbuvir for 12 weeks is safe and effective in children 3 to <6 years old with chronic HCV infection (oral presentation #0184)
Three year efficacy and safety of TAF compared to tenofovir disoproxil fumarate (TDF) in HBeAg-negative and HBeAg-positive patients with chronic hepatitis B (poster #0404)
Safety and efficacy at 1 year in post liver transplant patients with chronic kidney disease receiving tenofovir alafenamide for HBV prophylaxis (poster #1225)

EPCLUSA and HARVONI are each indicated in the U.S. for the treatment of chronic HCV infection in patients with no cirrhosis or compensated cirrhosis: EPCLUSA for adults with genotypes 1-6; and HARVONI for patients 12 years and older with genotypes 1, 4, 5 and 6. VEMLIDY is indicated for the treatment of chronic HBV infection in adults with compensated liver disease. The US product labels for EPCLUSA, HARVONI, and VEMLIDY each contain a BOXED WARNING: for EPCLUSA and HARVONI, the risk of hepatitis B reactivation in HCV/HBV co-infected patients; and for VEMLIDY, the risk of post-treatment acute exacerbation of HBV. See below for U.S. Important Safety Information.

The safety and efficacy of EPCLUSA in HCV patients undergoing dialysis and HARVONI in HCV patients ages 3 to up to 6 years of age have not been established.

Read full release: https://www.marketwatch.com/press-release/gilead-to-present-wide-ranging-new-data-on-treatment-and-diagnosis-of-liver-diseases-at-the-liver-meeting-2018-2018-10-11

For more information, including a complete list of abstract titles at the meeting, please visit: http://www.aasld.org/events-professional-development/liver-meeting.

Tuesday, October 2, 2018

Assembly Biosciences Announces Oral Presentation at 2018 AASLD

SAN FRANCISCO, Oct. 02, 2018 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today announced that the company will have an oral presentation of the full data set from the Phase 1b study of ABI-H0731 at the upcoming American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting®), being held November 9-13 in San Francisco.

The oral presentation at AASLD will review final results of the Phase 1b study in patients with chronic hepatitis B (HBV) infection, including safety, tolerability and pharmacokinetics of ABI-H0731 (or ‘731), as well as quantitative changes in HBV DNA, RNA and viral antigens. ABI-H0731 was safe and well tolerated, with dose dependent antiviral effects at doses ranging from 100 to 400 mg given orally once daily, and RNA declines paralleled the observed DNA declines. The company presented interim results of the study at the Annual Meeting of the European Association for the Study of the Liver (EASL) in April.

"We are pleased with the final results from the Phase 1b study, with viral load responses and a safety profile that solidly support our clinical strategy in the two Phase 2a trials currently underway in HBV patients," said Uri Lopatin, M.D., Chief Medical Officer. "Both trials are evaluating oral '731 at 300 mg once daily in combination with standard of care nucleos(t)ide therapy, with one trial enrolling treatment-experienced HBV patients with suppressed viral loads and the other enrolling treatment-naïve patients."

In July, the Company received FDA Fast Track Designation for ABI-H0731 and expects to report interim data from the Phase 2a trials during the first half of 2019. Assembly also plans to expand its clinical HBV pipeline later this year with the initiation of a Phase 1 study on its second, highly potent core inhibitor, ABI-H2158.

Oral Presentation
Title: Final Results of a Phase 1b 28-Day Study of ABI-H0731, a Novel Core Inhibitor, in Non-Cirrhotic Viremic Subjects with Chronic Hepatitis B

Session: Parallel 8: Novel Therapies for HBV
Room: 157/160, Moscone Center, North and South Buildings
Date:Sunday, November 11, 2018
Time:10:30am PT

Presenter: MF Yuen, MD, PhD, Chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, Hong Kong

About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live synthetic biotherapeutic candidates with Assembly's fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com.

Forward-Looking Statements
The information in this press release contains forward-looking statements regarding future events, including statements about the clinical and therapeutic potential of core inhibitors, including ABI-H0731 and ABI-H2158, Assembly's development programs, the results of clinical trials being predictive of future clinical trials, the initiation, progress and results of Assembly's ongoing and planned clinical studies and the timing of these events. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as "plan," "upcoming," "look forward," "will," "expected," and "potential." Assembly intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Assembly are more fully detailed under the heading "Risk Factors" in Assembly's Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the Securities and Exchange Commission. Except as required by law, Assembly assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Conatus Pharmaceuticals Announces Three Accepted Abstracts for AASLD Annual Meeting

Conatus Pharmaceuticals Announces Three Accepted Abstracts for AASLD Annual Meeting

SAN DIEGO, Oct. 02, 2018 (GLOBE NEWSWIRE) -- Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) announced today that two abstracts – one addressing clinical results with the company’s pan-caspase inhibitor, emricasan, and one addressing preclinical results with the company’s pan-caspase inhibitor, IDN-7314 – have been accepted for oral presentations; and one abstract addressing preclinical results with emricasan has been accepted for a poster presentation at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San FranciscoNovember 9-13, 2018. Accepted abstracts were published yesterday on the Hepatology website1.

Abstracts accepted for oral presentations included:
“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),” (abstract #1226, originally accepted as poster, later accepted as oral presentation); and

“Intestinal dysbiosis augments liver disease progression via NLRP3 in a murine model of primary sclerosing cholangitis,” (abstract #25);
and abstracts accepted for posters included:

“Molecular mechanisms underlying the effects of emricasan in portal hypertension and chronic liver disease: the hepato-sinusoidal cross-talk matters,” (abstract #1344).

Abstract #25 is an AASLD Foundation Abstract Award Recipient and was accepted for presentation in the Presidential Plenary Session on Translational Science and Genomics.

“As we advance toward releasing top-line results over the next 15 months from our three ENCORE Phase 2b clinical trials in patients with nonalcoholic steatohepatitis (NASH), the body of preclinical and clinical data documenting the activity and effects of pan-caspase inhibitors continues to grow,” said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D. “Thanks to the work of our principal investigators and our scientific collaborators, we have an ever-deepening understanding of the multiple mechanistic effects of caspase inhibitors on liver structure and function, as well as their disease-modifying potential. We are pleased with the recognition afforded to these latest developments at the upcoming AASLD meeting.”

About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development of novel medicines to treat liver disease. In collaboration with Novartis, Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, caspase inhibitors have the potential to interrupt the progression of a variety of diseases. For additional information, please visit www.conatuspharma.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding: the timeline for results from the ENCORE trials; and caspase inhibitors’ potential to modify disease and interrupt the progression of a variety of diseases. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including: the risk that the preclinical results may not be predictive of future clinical trial results; and those risks described in the company’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

1 Hepatology 68:S1 (October 2018) https://aasldpubs.onlinelibrary.wiley.com/journal/15273350.

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

http://www.genfit.com/wp-content/uploads/2018/10/2018.10.02-AASLD-2018-PR-EN-.pdf

The Liver Meeting® 2018 - Accepted Abstracts Now Available To The Public

The Liver Meeting® 2018
San Francisco, CA.
November 9-13, 2018.

Welcome Message
AASLD will see you in San Francisco, where more than 9,500 hepatologists and hepatology health professionals from across the nation and around the world will gather at The Liver Meeting® to exchange the latest liver diseases research, discuss treatment outcomes, and interact with colleagues at the annual must-attend even in the science and practice of hepatology.

Website
AASLD

AASLD - On Twitter
@AASLDtweets
#LiverMtg18 

Accepted Abstracts  
Now Available in the October 2018 HEPATOLOGY supplement.
The Liver Meeting® 2018

Late-breaking Abstracts
Late-breaking abstracts are available to the public on the AASLD website in early November, and are published in the December issue of HEPATOLOGY.