Positive data from a Phase II EVEREST combination study of danoprevir (ASC08A) and ravidasvir (ASC16) keeps Hangzhou-based biotech Ascletis Pharmaceuticals in hot contention to get the first modern hepatitis C (HCV) therapy approved in China.
The company said in a press release that interim data presented at the Asian Pacific Association for the Study of the Liver Single Topic Conference in HCV showed the Taiwan leg of the trial produced a 100% virologic response rate following 12 weeks of treatment.
According to Ascletis, the interim data presented of the virologic response of 38 Chinese HCV genotype 1 noncirrhotic patients is expected to show the primary endpoint was met when it releases the full results in September.
The focus in China for chronic hepatitis C is genotype 1b as nearly two-thirds of the 30 million estimated cases fall in that category.
The race to get China FDA approval for an interferon-free HCV therapy sees Gilead Sciences ($GILD) awaiting review completion even as the company negotiates with the government on a possible price. Johnson & Johnson ($JNJ) and Bristol-Myers Squibb ($BMY) are also on the pathway to bring direct-acting antivirals to approval in China.
But as a domestic firm, Ascletis has a leg up on the candidate--which was in-licensed from Roche ($RHHBY) in 2013--in a regulatory pathway it won in April that awards local manufacture and expedites China FDA approvals for domestic firms.
"I'm very glad that we received the priority review from CFDA and positive Phase II data for our IFN-free regimen," Jinzi Wu, founder, president and CEO of Ascletis said in a statement. "Ascletis is taking both triple and IFN-free regimens to market and providing quality and affordable treatment for Chinese HCV patients."
China's standard of care for HCV is a 48-week regimen of peginterferon with ribavirin, which sees many patients head abroad for front-line therapies.
Among funding sources, Ascletis raised $20 million from Goldman Sachs ($GS) in December of last year, building on $35 million in an earlier funding round led by C-Bridge Capital, with Tasly Pharma and Singapore-based Pavilion Capital offering support.
Ascletis also has candidates for the treatment of liver cancer licensed from Alnylam Pharmaceuticals ($ALNY) and Johnson & Johnson unit Janssen, ASC09, aimed at HIV.
- here's the release
Related Articles:
Ascletis gets $20M from Goldman in race to China HCV approval
BMS PhIII hep C combo results a milestone for China plans
China's Ascletis gets Taiwan nod for PhII trial of interferon-free HCV