Hangzhou, China (Jun. 24, 2015) – Ascletis today announced that clinical trial applications for its interferon (IFN)-free regimen to treat chronic hepatitis C (CHC) have been filed and accepted by both China Food and Drug Administration (CFDA) and Taiwan Food and Drug Administration (TFDA). Ascletis is now the first Chinese company to file clinical trial applications in China for an IFN-free regimen. This is a significant milestone following the completion of the successful IFN-containing phase II trial in Taiwan region with ASC08, the Company's leading direct-acting antiviral agent (DAA). This IFN-free regimen contains the NS3/4A inhibitor ASC08 and the NS5A inhibitor ASC16.
"All oral IFN-free regimens are breakthrough treatments of CHC marketed outside China at the end of 2014. To date, there are no DAAs approved in China," said Professor Zhuang Hui, academician of the Chinese Engineering Academy and the honorary Chairman of the Chinese society of Hepatology, at Peking University Health Science Center, "We're very pleased that Ascletis is developing the first IFN-free regimen by a domestic company for CHC in China. It shows that the domestic pharmaceutical companies are now catching up with the global development for CHC. This IFN-free regimen is significant for HCV patients in China."
"Following the recognition of ASC08 triple therapy for CHC at the Asian Pacific Association for the Study of Liver (APASL) annual meeting in March this year, Ascletis is now taking another big step toward development of a highly effective, IFN-free CHC treatment for Chinese patients ," said Jinzi J. Wu, Ph.D., Ascletis' founder, President and CEO.
Ascletis is planning several clinical studies to evaluate the combination of ASC08 and ASC16 to treat CHC in mainland China and Taiwan region in the near future.
ASC08, also known as Danoprevir, is a second-generation HCV NS3/4A protease inhibitor. It has been evaluated in 27 phase I and 7 phase II clinical trials with a total of approximately 2400 healthy volunteers and patients tested. DAPSANG (Phase II Study) results show that after 12-week treatment of ASC08 in combination with PEG-IFN and ribavirin, the SVR12 rate observed in genotype 1 non-cirrhotic patients in Taiwan was 94% and in genotype 1b non-cirrhotic patients in Taiwan the SVR12 rate was 100%. DAPSANG results were presented at the 2015 annual meeting of APASL and received one of the event's top honors, known as the Choices of President Awards.
ASC16, also known as Ravidasvir, an NS5A inhibitor and Ascletis' second DAA, is one of the best-in-class compounds. The results of a phase IIa clinical trial indicate that the IFN-free regimen containing ASC16 and other two DAAs was efficacious and safe in treating HCV genotype 1a infection. An SVR12 rate of 92% was observed after 12 weeks of treatment.
Ascletis is an emerging biotechnology company, dedicated to discovering, developing and commercializing important new treatments for infectious diseases and cancer. Ascletis is focused on clinical development of innovative medicines and commercialization for the growing Chinese pharmaceutical marketplace. Ascletis has assembled an entrepreneurial management and senior scientific team with a track record of successful pharmaceutical discovery and development at major global pharmaceutical and emerging biotechnology companies in the United States and Europe. To date the company has added four late-stage candidates to its product portfolio: ASC08, a clinical stage HCV protease inhibitor partnered with Roche; ASC16, a clinical stage HCV NS5A inhibitor licensed from Presidio Pharmaceuticals; ASC06, a clinical stage, first-in-class, systemically delivered RNAi therapeutic for the treatment of liver cancers licensed from Alnylam Pharmaceuticals; and ASC09, a next-generation HIV protease inhibitor licensed from Janssen, a pharmaceutical company of Johnson & Johnson. For more information, please visit www.ascletis.com outside China or www.ascletis.com.cn inside China.
Associate Director, BD