– Humanity & Health Research Centre conducting differentiated Phase 2a study evaluating CC-31244 for the ultra-short treatment of hepatitis C (HepC)
– Asia market represents one of the largest HepC virus carrier populations in the world
BOTHELL, WA, May 20, 2019 — Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics, announced today that it has commenced patient enrollment in its Phase 2a study in Hong Kong SAR, China.
The Phase 2a open-label study being conducted at Humanity & Health Research Centre, Humanity and Health Medical Group, in Hong Kong will evaluate the safety, tolerability and preliminary efficacy of Cocrystal’s CC-31244 in combination with Sofosbuvir and Daclatasvir with or without a protease inhibitor, for the treatment of hepatitis C (HepC). Sixteen patients will be enrolled in the Phase 2a study. This trial differs from the current Phase 2a trial Cocrystal is conducting in that testing will include for the first time a protease inhibitor.
Dr. George Lau commented, “We are pleased to commence patient enrollment in this important, differentiated Phase 2a study. I believe CC-31244 has the potential to be a shorter, safer and more effective treatment option for treating hepatitis C in the Asian population and where there remains a significant unmet need.”
Gary Wilcox, Chairman and Chief Executive Officer of Cocrystal stated, “The commencement of patient enrollment in this Phase 2a study represents a noteworthy accomplishment in our clinical development program for CC-31244. We are pleased to be working with the Humanity & Health Research Centre in Hong Kong and believe this study will provide valuable insight in this important market, representing one of the largest hepatitis C virus carrier populations in the world. We look forward to further understanding the potential to change the treatment paradigm for patients living with HCV by providing an ultra-short therapy to enhance the existing HepC combination therapies.”
Under the Clinical Trial Agreement, the Phase 2a study of CC-31244 for the treatment of HepC will be sponsored and conducted by the Humanity & Health Research Centre, Hong Kong under the guidance of George Lau, M.D., FRCP (Edin, Lond), FHKAM (Med), FHKCP, FAASLD, Founding Chairman of Humanity and Health Medical Group, Hong Kong. As part of the agreement, Cocrystal will provide CC-31244, its lead product in development for HepC. Cocrystal’s CC-31244 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.
About Humanity and Health Medical Group (HHMG)
Humanity and Health Medical Group (HHMG) is a private company, founded in 2009 by its Chairman, George Lau, MBBS (HKU), M.D. (HKU), FRCP (Edin, Lond), FHKAM (Med), FHKCP, FAASLD, who is also Chair Professor and co-Director, Liver Diseases & Transplant Centre, The Fifth Medical Centre of Chinese PLA General Hospital (former Beijing 302 Hospital), Beijing – Humanity & Health Medical Group, Beijing, China. HHMG provides high-end medical services to the community mainly in Hong Kong SAR, and Beijing, China. HHMG, focuses on liver diseases, gastrointestinal diseases, cardiovascular diseases, respiratory medicine, oncology and general surgery. These medical services are run by a group of senior specialist consultants, including the former Clinical Professor and Chair Professor and Dean of the HKU-LKS medical school, Hong Kong SAR, China, facilitated by the “smart-health-care system,” a state-of-the-art laboratory and imaging services. In addition, HHMG has been working closely with Beijing 302 Hospital, Beijing to run combined clinics and translational research center. With this collaboration, HHMG has become the largest HCV treatment center and private HBV treatment center, in Hong Kong. HHMG has also setup a clinical trial center, named Humanity and Health Research Center (HHRC) to do all Phase 2-4 US FDA-regulated and EU EMEA-regulated registration clinical trials in Hong Kong, in full compliance to ICH and GCH requirement.
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 influenza viruses, hepatitis C viruses, and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. The Company is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks. Cocrystal recently entered into an exclusive worldwide license and collaboration agreement with Merck & Co., Inc. to discover and develop certain proprietary influenza A/B antiviral agents. CC-42344, the Company’s molecule for the treatment of influenza A, is currently being evaluated in preclinical IND-enabling studies. In addition, the Company has a pipeline of promising early preclinical programs and continues to identify and develop non-nucleoside polymerase inhibitors for norovirus gastroenteritis using the Company’s proprietary structure-based drug design technology platform. 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 the prospects for CC-31244. 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, issues with the subjects selected by Dr. Lau’s company and the results which arise in the Hong Kong trial including efficacy of CC-31244 in combination with the other drugs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2018. 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.