China, Taiwan FDAs accept trial applications for IFN-free HCV regimen

The China and Taiwan Food and Drug Administrations have accepted clinical trial applications filed by Ascletis Innovation for its interferon-free regimen to treat chronic hepatitis C virus infection, according to a press release.

Ascletis is the first Chinese company to file clinical trial applications in China for an IFN-free regimen, according to the release, and will initiate a phase 2 trial in Taiwan. The trial will include a combination regimen of Danoprevir (ASC08), a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir (ASC16), an NS5A inhibitor.

“All oral IFN-free regimens are breakthrough treatments of [chronic hepatitis C] marketed outside China at the end of 2014. To date, there are no DAAs approved in China,” Zhuang Hui, MD, academician of the Chinese Engineering Academy and the honorary Chairman of the Chinese society of Hepatology at Peking University Health Science Center, said in the release. “We're very pleased that Ascletis is developing the first IFN-free regimen by a domestic company for [chronic hepatitis C] in China. It shows that the domestic pharmaceutical companies are now catching up with the global development for [chronic hepatitis C].”

According to the Ascletis website, chronic hepatitis C (CHC) is common and one of the main causes of cirrhosis and hepatocellular carcinoma in China. Approximately 200,000 cases of HCV were reported in 2014, a 15% increase compared to the previous year.

“Following the recognition of ASC08 triple therapy for CHC at the Asian Pacific Association for the Study of Liver 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 ,” Jinzi J. Wu, PhD, founder, president and CEO of Ascletis, said in the release.

Ascletis is currently planning multiple studies to assess the efficacy and safety of a combination of the two regimens for CHC in both China and Taiwan.

Reference:

Ascletis Website. Status and Treatment Trends of HCV in China. Available at: http://ascletis.com.cn/HCV.html. Accessed June 26, 2015.

Disclosures: Wu reports being employed by Ascletis. Healio.com/Hepatology was unable to confirm relevant financial disclosures for Hui at the time of publication.

The China and Taiwan Food and Drug Administrations have accepted clinical trial applications filed by Ascletis Innovation for its interferon-free regimen to treat chronic hepatitis C virus infection, according to a press release.

Ascletis is the first Chinese company to file clinical trial applications in China for an IFN-free regimen, according to the release, and will initiate a phase 2 trial in Taiwan. The trial will include a combination regimen of Danoprevir (ASC08), a direct-acting antiviral agent and NS3/4A inhibitor, and Ravidasvir (ASC16), an NS5A inhibitor.

“All oral IFN-free regimens are breakthrough treatments of [chronic hepatitis C] marketed outside China at the end of 2014. To date, there are no DAAs approved in China,” Zhuang Hui, MD, academician of the Chinese Engineering Academy and the honorary Chairman of the Chinese society of Hepatology at Peking University Health Science Center, said in the release. “We're very pleased that Ascletis is developing the first IFN-free regimen by a domestic company for [chronic hepatitis C] in China. It shows that the domestic pharmaceutical companies are now catching up with the global development for [chronic hepatitis C].”

According to the Ascletis website, chronic hepatitis C (CHC) is common and one of the main causes of cirrhosis and hepatocellular carcinoma in China. Approximately 200,000 cases of HCV were reported in 2014, a 15% increase compared to the previous year.

“Following the recognition of ASC08 triple therapy for CHC at the Asian Pacific Association for the Study of Liver 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 ,” Jinzi J. Wu, PhD, founder, president and CEO of Ascletis, said in the release.

Ascletis is currently planning multiple studies to assess the efficacy and safety of a combination of the two regimens for CHC in both China and Taiwan.

Reference:

Ascletis Website. Status and Treatment Trends of HCV in China. Available at: http://ascletis.com.cn/HCV.html. Accessed June 26, 2015.

Disclosures: Wu reports being employed by Ascletis. Healio.com/Hepatology was unable to confirm relevant financial disclosures for Hui at the time of publication.