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news.Scynexis, a drug discovery and development company, has reported positive results from a Phase Ib single-agent, randomized, double-blind, placebo-controlled study of its lead, oral, antiviral drug candidate, SCY-635, in adult patients with genotype 1 chronic hepatitis C infection.
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In this 15-day study, SCY-635 was well-tolerated with no serious adverse events, no discontinuations and no dose-limiting toxicities. At the highest dose tested in the study (900mg/day) SCY-635 exhibited clinically relevant antiviral activity and substantial suppression of plasma viremia throughout the treatment period. In the 900mg cohort all treated patients showed a viral load reduction with a group mean maximum decrease of 2.2log10 on the last day of the study (p < 0.05 for the day 15 comparison), the company said. The study was conducted in two parts. Approximately 36 subjects received SCY-635 once daily and 20 subjects received SCY-635 three times daily. All studies were conducted in the US. Yves Ribeill, president and CEO of Scynexis, said: "These results establish proof-of-concept for SCY-635 in hepatitis C virus patients and more broadly support our discovery platform, which is focused on the development of cyclophilin inhibitors for multiple diseases. "Given that we have seen no dose related adverse events at our highest tested dose, we are in the process of optimizing the dose and regimen of SCY-635 in ongoing Phase I studies and plan to initiate a Phase II study in patients infected with HCV in the second half of 2009."