Cocrystal Pharma Completes Patient Enrollment in Phase 2a Study Evaluating CC-31244 for Ultra-Short Treatment of Hepatitis C
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.
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.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of hepatitis viruses, influenza viruses, and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. CC-31244 is in a Phase 2a trial. It is a broad-spectrum novel non-nucleoside replication inhibitor of the hepatitis C virus. Phase 1b studies in HCV-infected patients showed the largest reduction in viral load of any non-nucleoside inhibitor tested to date. CC-31244 is now in clinical trials as part of a cocktail for ultra-short therapy of 6 weeks. The lead candidate for influenza has advanced to IND-enabling studies. It is effective in animal models against both the pandemic and seasonal strains of influenza. In addition, the Company has a pipeline of promising early preclinical programs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our expectations regarding the manner of conducting and future progress of the Phase 2a study, the progress of preclinical IND-enabling studies and regulatory submission and initiation of a Phase 1 study for the influenza inhibitor. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include the availability of products manufactured by third parties, receipt of regulatory approvals and the ability of the clinical research organizations conducting the Phase 2a study and the Phase 1 influenza study to recruit subjects. Further information on our risk factors is contained in our filings with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, the Prospectus Supplement dated April 30, 2018, and our Annual Report on Form 10-K for the year ended December 31, 2017. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Investor and Media Contact: Jenene Thomas Communications, LLC (833) 475-8247 COCP@jtcir.com
Released September 20, 2018