Ascletis is the first Chinese company to file clinical trial applications in China for an IFN-free regimen, according to the release, and will initiate a phase 2 trial in Taiwan. The trial will include a combination regimen of Danoprevir (ASC08), a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir (ASC16), an NS5A inhibitor.
According to the Ascletis website, chronic hepatitis C (CHC) is common and one of the main causes of cirrhosis and hepatocellular carcinoma in China. Approximately 200,000 cases of HCV were reported in 2014, a 15% increase compared to the previous year.
“Following the recognition of ASC08 triple therapy for CHC at the Asian Pacific Association for the Study of Liver annual meeting in March this year, Ascletis is now taking another big step toward development of a highly effective, IFN-free CHC treatment for Chinese patients ,” Jinzi J. Wu, PhD, founder, president and CEO of Ascletis, said in the release.
Ascletis is currently planning multiple studies to assess the efficacy and safety of a combination of the two regimens for CHC in both China and Taiwan.