Ultra-Short Treatment of Hepatitis C - Cocrystal Pharma Completes Patient Enrollment in Phase 2a Study Evaluating CC-31244

ATLANTA, GA and BOTHELL, WA, Sept. 20, 2018 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of hepatitis viruses, influenza viruses and noroviruses, announced today the completion of patient enrollment in its Phase 2a clinical study evaluating CC-31244 for the ultra-short treatment of hepatitis C virus (HCV)-infected individuals.

CC-31244, the Company’s lead product in development for hepatitis C (HepC), is an investigational, oral, potent, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). It has a high barrier to drug resistance designed and developed using the Company's proprietary structure-based drug discovery technology. It is active against HCV genotypes 1-6 with no significant cytotoxicity in multiple cell types at high concentrations.

“A major focus this year for Cocrystal has been the execution of our Phase 2a HepC study with our lead program CC-31224 combined with Epclusa. The on-time completion of patient enrollment marks a significant milestone for the Company and a testament to the focus as well as the expertise of our clinical team,” commented Gary Wilcox, Ph.D., Vice Chairman and Chief Executive Officer of Cocrystal. “We are pleased that there were no serious adverse events observed and that the combination was well tolerated in all patients. We now look forward to the completion of patient dosing and announcement of initial results in Q4.”

The Phase 2a open-label study is designed to evaluate the safety, tolerability and preliminary efficacy of CC-31244 with Gilead Science’s Epclusa®. Enrolled subjects self-administer orally 400 mg of CC-31244 and a fixed dose of Epclusa for 14 days. After 14 days the subjects continue the treatment for another four weeks on Epclusa alone. Primary and secondary efficacy endpoints are sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) and at 24 weeks post-treatment (SVR24), respectively.

Joel Chua, M.D., Assistant Professor of Medicine and Principal Investigator of the Phase 2a study Institute of Human Virology at the University of Maryland School of Medicine, commented, “I am pleased with the progression of the Phase 2a study of CC-31244 and believe it has significant potential to address the need for treatment options with ultra-short duration for individuals chronically infected with hepatitis C.”

For additional information about the Phase 2a study of CC-31244 for the treatment of viral hepatitis C, please visit ClinicalTrials.gov and reference identifier NCT03501550.

About CC-31244
CC-31244 is an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). It has been designed and developed using the Company's proprietary structure-based drug discovery technology to have a high barrier to drug resistance and to be a highly potent, selective NNI that is active against all HCV genotypes (1-6) with low level cytotoxicity in multiple cell types.

About Hepatitis C

Hepatitis C is a viral infection of the liver that causes both acute and chronic infection, and according to the World Health Organization in 2017, affects an estimated 71 million people worldwide, including 3.5 million in the United States. Chronic hepatitis C virus infection can lead to fibrosis (scarring), cirrhosis, liver failure, and liver cancer. Approximately 399,000 people die each year from hepatitis C, mostly from cirrhosis and hepatocellular carcinoma.

https://globenewswire.com/news-release/2018/09/20/1573658/0/en/Cocrystal-Pharma-Completes-Patient-Enrollment-in-Phase-2a-Study-Evaluating-CC-31244-for-Ultra-Short-Treatment-of-Hepatitis-C.html

Cocrystal Pharma Receives FDA Clearance to Initiate Phase 2a Clinical Study Evaluating CC-31244 for Hepatitis C

Cocrystal Pharma Receives FDA Clearance to Initiate Phase 2a Clinical Study Evaluating CC-31244 for the Treatment of Hepatitis C Virus

ATLANTA, GA and BOTHELL, WA, April 03, 2018 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of hepatitis viruses, influenza viruses and noroviruses, announced today that its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) is now open and the Company is cleared to initiate its Phase 2a clinical study evaluating CC-31244 for the treatment of hepatitis C virus (“HCV”) infected individuals.

Gary Wilcox, Vice Chairman and Interim Chief Executive Officer of Cocrystal, commented, “The achievement of this regulatory milestone is a significant step forward in the advancement of our lead program, CC-31244. Based on the positive results from our Phase 1a/1b study, we believe that CC-31244 has the potential to change the treatment paradigm for patients living with HCV providing a shorter therapy with existing HCV combination therapies and a substantial and durable antiviral effect. We look forward to further evaluating the effect of CC-31244 and the commencement of this next phase of clinical development.”

CC-31244, the Company’s lead product in development, is an investigational, oral, highly potent, broad-spectrum non-nucleoside inhibitor with high barrier to drug resistance designed and developed using the Company's proprietary structure-based drug discovery technology. CC-31244 is active against all six HCV genotypes, with low level cytotoxicity in multiple cell types.

The Phase 2a study is an open-label study designed to evaluate the safety, tolerability and preliminary efficacy of CC-31244 with approved HCV drugs. Endpoints of the Phase 2a study include changes in HCV RNA viral load, adverse events and laboratory abnormalities. Cocrystal expects to commence its Phase 2a study of CC-31244 in the second quarter of 2018 and announce data in the fourth quarter of this year.

In August 2017, the Company announced positive data from the Phase 1a/1b trial of CC-31244 for the treatment of chronic hepatitis C infection. This randomized, placebo-controlled, double-blind Phase 1a/1b study evaluated single and multiple ascending doses of CC-31244 for safety/tolerability, pharmacokinetics, and antiviral activity in healthy volunteers and patients with HCV infection. In Phase 1a, 30 healthy volunteers received single doses (20-400 mg) of CC-31244, and 12 healthy volunteers received repeated doses of CC-31244 (either 200 or 400 mg) for 7 days. In Phase 1b, 15 patients with HCV genotype-1 infection received CC-31244 for 7 days (6, 400 mg daily; 6, 600 mg daily; 3, 200 mg twice daily). Eighteen subjects received placebo during the study.

As reported, there were no dose-limiting adverse events, study discontinuations due to adverse events, or serious adverse events. Viral load data showed that CC-31244 administered once daily (400 mg or 600 mg) or twice daily (200 mg) for 7 days had a substantial and durable antiviral effect, with an average HCV RNA viral load decline from baseline of 1000-fold by Day 4. Interestingly, the average viral load at 6 days after the last dose persisted in the range of 100-fold below baseline. HCV genotype 1b cell-based replicon assays using combinations of CC-31244 with other classes of HCV drugs showed additive and synergistic effects of CC-31244, providing important information for ultra-short therapy cocktail regimens.

https://www.cocrystalpharma.com/news/press-releases/detail/46/cocrystal-pharma-receives-fda-clearance-to-initiate-phase

APASL-Cocrystal Pharma to Present Data on Pan-genotypic NS5B Non-nucleoside Inhibitor CC-31244 for the Treatment of Hepatitis C Virus Infection

Cocrystal Pharma to Present Clinical Data on its Potent Pan-genotypic NS5B Non-nucleoside Inhibitor CC-31244 at the Asian Pacific Association for the Study of the Liver (APASL) Annual Meeting
Posted on: 16 Feb 17

BOTHELL, Wash. and ATLANTA, Feb. 16, 2017 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (OTCQB:COCP), a company focused on developing novel antiviral therapeutics for human diseases, announced today that it has been selected to give an oral presentation on Saturday, February 18, 2017, 3:45 PM Shanghai time (2:45 AM ET) entitled, “Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of CC-31244, a Pan-Genotypic, Potent Non-Nucleoside NS5B Polymerase Inhibitor for the Treatment of Hepatitis C Virus Infection” at the 26th Conference of the Asian Pacific Association for the Study of the Liver (APASL) held in Shanghai, February 15-19, 2017.

The interim results from the ongoing, randomized, double-blind, Phase 1a/1b study of CC-31244, a pan-genotypic, potent NS5B non-nucleoside inhibitor (NNI) will be presented by Sam Lee, Ph.D., President and co-inventor of the drug. CC-31244 monotherapy produced up to a 3 log drop in viral load with a slow viral rebound post treatment following a 7 day treatment suggesting that CC-31244 could be an important component in an all oral, shorter HCV combination therapy.

Cocrystal Pharma's interim Chief Executive Officer, Dr. Gary Wilcox said, "We are pleased to be given the opportunity to present the interim data at APASL. The interim results show that CC-31244 had a substantial and durable antiviral effect with a favorable safety and tolerability profile in both healthy volunteers and HCV GT1 infected individuals.”

An archived edition of the presentation will be available on the Cocrystal website, www.cocrystalpharma.com, shortly after the event.

About CC-31244
CC-31244 is an investigational, oral, potent, pan-genotypic NNI with high barrier to drug resistance designed and developed using the Company's proprietary structure-based drug discovery technology. The molecule interacts with the NS5B RNA polymerase of all major HCV genotypes.

More: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=206045#.WKYUwIWcGmQ#ixzz4YsvAd0wa

CC-31244 - Cocrystal Announces Positive Interim Data from an Ongoing Phase 1 Study for Hepatitis C

Cocrystal Announces Positive Interim Data from an Ongoing Phase 1 Study with CC-31244 for the Treatment of Chronic Hepatitis C Infection
November 07, 2016

ATLANTA, GA and BOTHELL, WA -- (Marketwired) -- 11/07/16 -- Cocrystal Pharma, Inc. (OTCQB: COCP), announced positive data from a randomized, double-blind Phase Ia/Ib study of CC-31244, a pan-genotypic, potent NS5B non-nucleoside inhibitor (NNI), for the treatment of chronic hepatitis C virus (HCV) infection.

The study is designed to evaluate CC-31244's safety/tolerability and pharmacokinetics, including food effect and antiviral activity. The study includes two groups: Group A (single ascending doses, and multiple doses in healthy volunteers), and Group B (multiple doses in HCV infected individuals).

The study has dosed a total of 42 healthy volunteers with single (20, 50, 100, 200 and 400 mg) and multiple doses of CC-31244 at 200 and 400 mg for 7 days. Five HCV GT1 infected patients were dosed, four with 400 mg of CC-31244 once daily for 7 days and one with placebo.

Data from the once daily 400 mg dosing arm demonstrate that CC-31244 had a substantial and durable antiviral effect with an average HCV RNA viral load decline from baseline of 3 log orders by 48 hours after dosing. The average viral load at 6 days post last dose remained on average 1.9 log orders below baseline. In addition, no viral breakthrough was observed during the treatment period. No serious adverse event was reported.

"To date, CC-31244 appears to be safe and well tolerated in both healthy and HCV-infected subjects. This study is ongoing with additional cohorts and Cocrystal anticipates reporting the complete dataset by the first quarter of 2017," said Gary L. Wilcox, Ph.D., Interim Chief Executive Officer of the Company. "The human pharmacokinetic and safety data were consistent with the drug's preclinical profile."

"Our initial clinical data are particularly encouraging. Our preclinical data indicate that the drug accumulates significantly in the liver. These data support the notion that CC-31244 is a potential best-in-class NNI which could be used as an important component in an all oral, ultra-short HCV combination therapy," added Sam Lee, Ph.D., President and co-inventor of this drug.

About CC-31244

CC-31244 is an investigational, oral, potent, pan-genotypic NNI with high barrier to drug resistance designed and developed using the Company's proprietary structure-based drug discovery technology. The molecule interacts with the NS5B RNA polymerase of all major HCV genotypes

About Hepatitis C

Hepatitis C is a viral infection of the liver that according to The World Health Organization in 2013 affects over 150 million people worldwide of whom only about 1% have been cured to date. The annual number of deaths due to Hepatitis C is estimated at 350,000 globally or nearly 1,000 per day. Most patients develop chronic infections, which can lead to fibrosis (scarring), cirrhosis, liver failure, and liver cancer. The worldwide market for hepatitis C antiviral drugs was $12 billion in 2015.

About Cocrystal Pharma

Cocrystal is a pharmaceutical company seeking to discover and develop novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. Cocrystal employs unique structure based technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies, including our nucleoside chemistry expertise, are designed to efficiently deliver small molecule therapeutics that are safe, effective and convenient to administer. The company has identified promising, preclinical stage antiviral compounds for unmet medical needs including hepatitis, influenza and norovirus infections. Cocrystal has previously received strategic investments from Teva Pharmaceuticals, OPKO Health, Brace Pharmaceutical, LLC, and The Frost Group. For further information about Cocrystal, please refer to www.cocrystalpharma.com.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Cocrystal, they are forward-looking statements reflecting the current beliefs and expectations of management including statements regarding development plans for treatments related to Hepatitis C. Forward-looking statements in this release include any implication that our future clinical results will be comparable to our initial data, and involve substantial risks and uncertainties that could cause our clinical development programs, performance or future results to differ significantly from what is expressed or implied by the forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Cocrystal has made with the Securities and Exchange Commission.

Contact:
Tricia Truehart
ttruehart@troutgroup.com

Source: Cocrystal Pharma, Inc.

Released November 7, 2016