Ascletis Completed Bridging Study of ASC18, a One-pill, Once-a-day Complete HCV Oral Regimen

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Aug 20, 2020, 08:00 ET

HANGZHOU and SHAOXING, China, Aug. 20, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) announces today that it completed bridging study of ASC18, first one-pill, once-a-day fixed dose combination (FDC) as the complete hepatitis C treatment developed by a Chinese biotech.

ASC18 FDC consists of 200 mg Ravidasvir (RDV) and 400 mg Sofosbuvir (SOF). This phase I bridging study was a randomized, two arms [ASC18 FDC tablet and (RDV 200 mg + SOF 400 mg given in separate pills)], two cycles, two phases (single dose phase and multiple dose phase), two-sequence crossover design. The results from this phase I bridging study (n=20 subjects) indicated that ASC18 FDC one-pill once-a-day showed comparable pharmacokinetics (PK), safety and tolerability with RDV 200 mg + SOF 400 mg given in separate pills. ASC18 FDC will further enhance Ascletis' competitiveness in HCV marketplace.

The STORM-C-1 phase II/III trial, conducted by Drugs for Neglected Diseases initiative (DNDi) and reported at the International Liver Conference in Paris on April 12, 2018, enrolled 300 HCV patients administered with separate 200 mg RDV tablet plus 400 mg SOF tablet for 12 weeks for patients without liver cirrhosis and for 24 weeks for those with compensated cirrhosis. The results showed an overall cure rate (Sustained Virological Response, SVR12) of 97%, 96% in cirrhotic subjects, and high cure rates (SVR12) across the genotypes studied: genotype 1a: 99%, 1b: 100%, 3a: 96%, 3b:100%, and 81% among the small group of genotype 6 subjects. The cure rates (SVR12) are high for people living with HIV using their usual treatment (97%) and people infected with genotype 3 (97%) including those with cirrhosis (96%).

On July 29, 2020, Ascletis received NDA approval of its first all-oral HCV treatment (RDV/DNV Regimen) by China's National Medical Products Administration (NMPA). RDV/DNV Regimen is Ravidasvir (Asclevir®) in combination with Danoprevir (Ganovo®), demonstrating a cure rate (SVR12) of 99 % with a short treatment duration of 12 weeks in genotype 1 non-cirrhotic patients. In patients with baseline NS5A resistance mutations, RDV/DNV Regimen demonstrated a cure rate (SVR12) of 100%.

"While the treatment of HCV has been transformed in recent years, there are still some considerations for selecting appropriate treatment regimens, including genotype, resistance mutation, liver disease severity and HCV/HIV co-infection," said Dr. Handan He, Chief Scientific Officer of Ascletis, "ASC18 FDC is the first one-pill, once-a-day complete oral regimen for HCV treatment developed by a Chinese biotech and an upgraded version of RDV/DNV regimen."

About Ascletis

Ascletis is an innovative R&D driven biotech with three commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing antiviral, steatohepatitis, and tumor-related innovative drugs for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis' pipeline is focused primarily on three therapeutic areas: 1. HCV: two commercial stage products and two R&D stage drug candidates. Ganovo® (Danoprevir) is the first direct-acting anti-viral agent for hepatitis C, developed by a domestic firm in China. Asclevir® (Ravidasvir) in combination with Ganovo® (Danoprevir) (RDV/DNV Regimen) is the first all-oral HCV regimen developed by a domestic company in China. 2. HBV: one commercial stage product and three R&D stage drug candidates. Pegasys® (Peginterferon alfa-2a) is a leading marketed pegylated interferon for hepatitis B&C partnered with Roche. 3. NASH (Non-Alcoholic SteatoHepatitis): three R&D stage drug candidates against three different targets for combination treatments. For more information, please visit www.ascletis.com.

SOURCE Ascletis Pharma Inc.