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.
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