- New data to be presented from U.S. Phase 2a clinical trial of CC-31244 for ultrashort treatment of hepatitis C virus (HCV)
- Eight of 12 patients achieved primary endpoint of sustained virologic response (SVR) 12, which is considered a cure, using only 6 weeks of Epclusa’s therapy combined with only 2 weeks of CC-31244
- New data indicates patients that achieved SVR had significantly higher frequencies of terminally differentiated effector memory CD8+ T cells compared with those who relapsed, allowing identification of patients more likely to respond to ultrashort treatment
BOTHELL, WA, Oct. 30, 2019 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics, today announced that its poster demonstrating positive data from its triple regimen, U.S. Phase 2a study evaluating CC-31244 and sofosbuvir/velpatasvir (Epclusa) for the ultra-short treatment of HCV infected individuals was selected for presentation at the American Association for the Study of Liver Diseases (AASLD) 2019 Liver Meeting being held November 8-12, 2019 in Boston, MA.
“We are pleased to be presenting this positive data at the AASLD 2019 meeting. There remains a major global barrier in the treatment of chronic HCV with the high cost of currently approved combination direct-acting antiviral (DAA) therapy of 8- and 12-weeks duration. CC-31244 seeks to provide a shorter duration therapy that maintains the high cure rates of currently available therapy, ultimately reducing the cost and improving adherence. We are encouraged by the data presented in our poster which suggests that we can identify the patients that are more likely to respond to our shorter treatment and look forward to advancing the development of ultrashort duration HCV therapy,” commented Dr. Sam Lee, President of Cocrystal.
Joel Chua, MD, Assistant Professor of Medicine of the Institute of Human Virology at the University of Maryland School of Medicine and Principal Investigator of the trial commented, “CD8+ effector T cell phenotypes are associated with virological cure when given in combination with CC-31244 and SOF/VEL in adults with chronic HCV. Identifying these select patients is the key to clinical development of ultrashort duration HCV therapy."
The details for the Company’s poster presentation are as follows:
Presenting Author: Joel Chua, MD
Abstract Title: Immune Cell Phenotypes Associated with Successful Response to 2 Weeks of a Novel Non-Nucleoside Inhibitor CDI-31244 Concurrent with 6 Weeks of Sofosbuvir/Velpatasvir in Subjects with Chronic Hepatitis C Genotype 1 Infection. Poster 1673
Presentation Date: Sunday, November 10, 2019
Presentation Time: 8:00 AM – 5:00 PM ET
For additional information about the U.S. Phase 2a study of CC-31244 for the treatment of viral hepatitis C, please visit ClinicalTrials.gov and reference identifier NCT03501550.
About the AASLD 2019 Liver Meeting
AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists (including Hans Popper, Leon Schiff, Fred Hoffbauer, Cecil Watson, Jesse Bollman, and Sheila Sherlock, to name a few) to bring together those who had contributed to the field of hepatology.
The annual AASLD Liver Meeting has grown to an international society responsible for all aspects of hepatology, and our annual meeting, AASLD, has grown in attendance from 12 to more than 12,500 physicians, surgeons, researchers, and allied health professionals from around the world. For more information, please visit the conference website.
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 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 novel antivirals for the treatment of norovirus gastroenteritis using the Company’s proprietary structure-based drug design technology platform. 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 the prospects for advancing the development of ultrashort duration HCV therapy, the prospects for CC-31244 and CC-42344 and the Company’s pipeline of promising preclinical programs. 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, but are not limited to, risks arising from our reliance on continuing collaboration with Merck under the collaboration agreement, the availability of products manufactured by third parties, the future results of preclinical and clinical studies, the research organization’s inability to recruit subjects and complete the Phase 2a study in a timely manner or at all, including as the result of civil unrest and political instability in Hong Kong, general risks arising from clinical trials, receipt of regulatory approvals, our ability to find and enter into agreements with suitable collaboration partners, unanticipated litigation and other expenses and factors that affect the capital markets in general and early stage biotechnology companies specifically. 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 and the Form 10-Q for the quarter ended June 30, 2019. 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:
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