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Ascletis receives Taiwan approval to start Phase II clinical trial for all-oral interferon-free regimen to treat chronic hepatitis C
2 September 2015 - The Taiwan Food and Drug Administration has granted approval to Ascletis, a company that focuses on building a global specialty therapeutics business, to commence a Phase II clinical trial for its all-oral interferon-free regimen to treat chronic hepatitis C, it was reported yesterday.The clinical trial is named EVEREST and will assess the antiviral activity, safety and pharmacokinetics of a combination regimen of Danoprevir, a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir, 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 percent 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. 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.'
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