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news.Ascletis has secured approval from the Taiwan Food and Drug Administration (TFDA) to start Phase II clinical trial for its all-oral interferon (IFN)-free regimen to treat chronic hepatitis C (CHC).
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The clinical trial, dubbed EVEREST, will evaluate the antiviral activity, safety and pharmacokinetics of a combination regimen of Danoprevir (ASC08), a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir (ASC16), an NS5A inhibitor, in treatment-naive patients with HCV genotype 1 without cirrhosis.
Both the direct-acting antiviral agents have been tested in several trials of over 2,000 patients and yielded sustained virologic responses of more than 90% after 12 weeks of treatment.
Ascletis founder, president and CEO Jinzi Wu said: "Therapies based on DAAs have predominated the CHC markets in the developed countries; however, there are no DAAs approved in China yet and the combination of PEG-interferon-alpha and ribavirin is still widely used as the Standard of Care (SoC).
"It is Ascletis’ vision to bring breakthrough treatments to the Chinese market. With two DAAs in the pipeline, we are developing a triple therapy (ASC08 in combination of PEG-IFN/ribavirin for 12 weeks) and an all-oral-IFN-free therapy to meet different clinical needs of the patients."
Earlier this year, Ascletis submitted the clinical trial application for the same IFN-free regimen with China Food and Drug Administration (CFDA).
The company plans to bring both triple and IFN-free therapies to the marketplace to address several clinical requirements of Chinese patients.