Ascletis receives TFDA approval to begin Phase II trial of interferon-free HCV regimen

Ascletis today announced it received the approval from the Taiwan Food and Drug Administration (TFDA) to start phase II clinical trial for its all-oral interferon (IFN)-free regimen to treat chronic hepatitis C (CHC). The regimen contains Ascletis' two direct-acting antiviral agents (DAA), the NS3/4A protease inhibitor ASC08 and the NS5A inhibitor ASC16. The investigator meeting for study initiation was held in Taipei yesterday and the trial will be conducted at 6 major hospitals in Taiwan starting in September 2015，led by principal investigator Prof. Jia-Hoang Kao, MD, Director of Clinical Research Institute at Taiwan University.

The phase II study, named EVEREST, is designed to evaluate the antiviral activity, safety and pharmacokinetics of the regimen. Treatment-naive HCV genotype 1 non-cirrhotic patients will be enrolled and dosed for 12 weeks. The primary endpoint is sustained virologic response at 12 weeks post-treatment (SVR12). Both ASC16 and ASC08 are well tolerated and have shown strong antiviral activity in prior clinical trials, respectively. Combining the two inhibitors, without interferon, is anticipated to increase antiviral efficacy and has a higher barrier to resistance.

"Due to the long treatment duration, significant adverse effects and various kinds of contraindications, many patients cannot tolerate treatment with interferon," 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, "Ascletis is the first domestic company in China to conduct clinical trials of an all-oral IFN-free HCV regimen. This is exciting news for all Chinese HCV patients. We hope the data to be generated in the EVEREST study can accelerate the approval process in mainland China and Taiwan, as new treatment options are urgently needed to reduce HCV prevalence in China."

"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 (SoC)," said Jinzi J. Wu, Ph.D., Ascletis' founder, President and CEO. "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. We believe that the EVEREST study will provide safety and efficacy data to support further development to the market since we want to bring Chinese HCV patients an affordable all-oral IFN-free regimen."

Ascletis also filed earlier this year the clinical trial application for the same IFN-free regimen with China Food and Drug Administration (CFDA).With the successful phase II study of its triple therapy at the beginning of 2015, Ascletis aims to bring both triple and IFN-free therapies to the marketplace to meet different clinical needs of Chinese patients.