Ascletis has become the first Chinese company to file clinical applications for an interferon-free hepatitis C virus treatment.
Clinical trial applications have been filed and accepted by the China Food and Drug Administration and the Taiwan Food and Drug Administration for ASC08 and ASC16 in chronic hepatitis C. This follows the completion of the successful interferon-containing phase II trial in Taiwan, the company’s leading direct-acting antiviral agent. The interferon-free regimen contains the NS3/4A inhibitor ASC08 (danoprevir) and the NS5A inhibitor ASC16 (ravidasvir). It has been evaluated in 27 Phase I and 7 Phase II trials.
Jinzi Wu, president and chief executive of Ascletis, said:"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 chronic hepatitis C treatment for Chinese patients.”
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