Cocrystal Pharma Announces Clinical Trial Agreement for Investigator-Initiated Phase 2a Study in Hong Kong of CC-31244 for Ultra-Short Treatment of Hepatitis C Virus
- Humanity & Health Research Centre to conduct Phase 2a study evaluating CC-31244 for the treatment of hepatitis C
- Asia market represents one of the largest hepatitis C virus carrier populations in the world
ATLANTA, GA and BOTHELL, WA, Oct. 08, 2018 (GLOBE NEWSWIRE) -- 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 signed a Clinical Trial Agreement for an investigator-initiated study with the Humanity & Health Research Centre, Hong Kong, PR China.
Under the Clinical Trial Agreement, the Phase 2a study of CC-31244 for the treatment of hepatitis C (HepC) will be sponsored and conducted by the Humanity & Health Research Centre, Hong Kong under the guidance of Dr. George Lau, MBBS (HKU), M.D. (HKU), FRCP (Edin, Lond), FHKAM (Med), FHKCP, FAASLD, Chairman of Humanity and Health Medical Centre, 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.
Dr. George Lau, stated, “There remains a huge unmet need for shorter, safe and effective treatment options for treating hepatitis C in the Asian population. The World Health Organization estimates that 71 million people are chronically infected with the hepatitis C virus worldwide. Approximately 399,000 cases of death each year are due to hepatitis C infection. The prevalence of hepatitis C in the Asian population has been estimated to be more than 1%, making it one of the largest hepatitis C virus carrier populations in the world. Clinical data on CC-31244 has been very compelling and has demonstrated promise in the potential to provide an ultra-short therapy to patients. I look forward to the commencement of this Phase 2a study.”
The upcoming, Hong Kong Phase 2a open-label study will evaluate the safety, tolerability and preliminary efficacy of CC-31244 in combination with Sofosbuvir and Daclatasvir with or without a protease inhibitor, for the treatment of 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. The Humanity & Health Research Centre expects to commence the study in Q4 2018.
“We are pleased to move forward with this clinical trial agreement to further study CC-31244 for the treatment of HepC and believe it will provide valuable insight in this important market. We are grateful to the Humanity & Health Research Centre for sponsoring and conducting the study and 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 hepatitis C combination therapies,” commented Gary Wilcox, Vice Chairman and Chief Executive Officer of Cocrystal.
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 Company’s lead candidate for influenza 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our expectations regarding the timing for the initiation and future progress of the Hong Kong Phase 2a study. 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 Hong Kong clinical research organization 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.
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Investor and Media Contact: Jenene Thomas Communications, LLC (833) 475-8247 COCP@jtcir.com
Released October 8, 2018