ARTICLE | Clinical News

Ascletis to start Phase II HCV trial in Taiwan

September 1, 2015 1:31 AM UTC

Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) said Taiwan FDA approved the start of the Phase II EVEREST trial of danoprevir ( ASC08) plus ASC16 ( PPI-668) to treat HCV. Ascletis intends to enroll treatment-naive, non-cirrhotic patients with HCV genotype 1 infection in EVEREST, beginning in September.

A clinical trial application (CTA) for the HCV regimen is under China Food and Drug Administration (CFDA) review. In June, Ascletis said it was the first Chinese company to submit CTAs in China for an interferon-free HCV regimen (see BioCentury Extra, June 24). ...