Hangzhou and Shaoxing, China (Nov. 6, 2018) -- Ascletis Pharma Inc. (1672.HK), a commercial-stage biotechnology company developing innovative drugs to address unmet needs in anti-viral, cancer and fatty liver disease therapeutic areas, announces today that a phase II / III clinical study of its all-oral HCV treatment （RDV/DNV Regimen） has been selected by AASLD’s Scientific Program Committee as a Poster Presentation. The presentation will be delivered at the 69th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), being held November 9-13, 2018，in San Francisco, CA. Prof. Lai Wei, the principal investigator of the study, will present the study at 14:00 PST, Nov. 12th. The presentation will be the first innovative direct-acting antiviral agent (DAA) developed by a Chinese domestic company to be accepted by the annual meeting of AASLD.
In this multi-center, randomized, double blind, placebo-controlled phase II / III trial, named Efficacy and Safety of All-Oral, 12-Week Ravidasvir Plus Ritonavir-Boosted Danoprevir and Ribavirin in Treatment-naïve Non-Cirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial in China，a total of 424 treatment-naïve, non-cirrhotic adult HCV GT1 patients were enrolled and treated. The primary efficacy endpoint was the rate of sustained virologic response 12 weeks after the end of treatment (SVR12) and the safety was evaluated and compared between treatment and placebo groups. The results show that RDV/DNV Regimen demonstrated a cure rate of 99% (SVR12) with a short treatment duration of 12 weeks in treatment-naïve non-cirrhotic HCV genotype 1 Chinese patients. In patients with baseline NS5A resistance mutations, RDV/DNV Regimen demonstrated a cure rate of 100% (SVR12).
Ravidasvir is a next-generation, best-in-class and pan-genotypic HCV NS5A inhibitor with a high genetic barrier to resistance developed by Ascletis. Globally, Ravidasvir has completed three phase III clinical trials with more than 1,000 patients enrolled. Ravidasvir in combination with danoprevir is the first all-oral interferon-free HCV regimen developed by a domestic company in China. Danoprevir NDA was approved on June 8, 2018; Ravidasvir NDA was accepted by CFDA on August 1, 2018 and designated for Priority review on October 17, 2018 to shorten an approval timeline.
Details of presentation are listed below
Poster Title: “Efficacy and Safety of All-Oral, 12-Week Ravidasvir Plus Ritonavir-Boosted Danoprevir and Ribavirin in Treatment-Na.ve Non-Cirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial in China”
Presenter：Prof. Lai Wei
Date and Time: 14:00 PST, Nov 12th, 2018
Location: Moscone Center North/South Building, Hall C