Cocrystal Pharma announces safety, preliminary efficacy data for CC-31244

Cocrystal Pharma (COCP) announced safety and preliminary efficacy data for its U.S. Phase 2a study evaluating CC-31244 for the ultra-short treatment of HCV infected individuals. CC-31244 is an investigational, oral, potent, broad-spectrum replication inhibitor called a non-nucleoside inhibitor, or NNI. Epclusa is an approved 12-week therapy for HCV developed by Gilead (GILD). The U.S. Phase 2a study is an open-label study designed to evaluate the safety, tolerability, and preliminary efficacy of CC-31244 with Epclusa in 12 subjects with treatment-naive HCV genotype 1. Subjects received oral 400 mg of CC-31244 and Epclusa for 2 weeks. Following this, the subjects continued Epclusa treatment alone for another 4 weeks. All subjects completed the 6-week treatment regimen. The treatment was well tolerated with no study discontinuations due to adverse events. Eight of 12 subjects achieved the primary efficacy endpoint of sustained virologic response at 12 weeks after completion of treatment, or SVR12. SVR12 is defined as undetectable virus in blood 12 weeks after completion of treatment and considered a virologic cure. Plans are underway to commence the second study in the HCV clinical development program, a Phase 2a study in Hong Kong evaluating the safety, tolerability and preliminary efficacy of CC-31244 in combination with sofosbuvir and daclatsavir with or without a protease inhibitor, for the treatment of hepatitis C. The Humanity & Health Research Centre expects to commence the study in Q1. The upcoming, Hong Kong Phase 2a open-label trial differs from the current Phase 2a trial Cocrystal is conducting by use of a protease inhibitor as part of the combination regimen and a shorter treatment duration.

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