Anadys gets a boost from positive PhIIb hep C study

Shares of San Diego-based Anadys ($ANDS) got a bump this morning on the news that its interim data from a Phase IIb study of its hepatitis C drug setrobuvir looks positive, helping to position the developer as it angles for a place at the table for future drug cocktails.

While an earlier study had run into trouble with a high placebo response, investigators say this time that the drug, formerly known as ANA598, beat out the placebo group. And the data may temper concerns about the number and severity of rashes that develop among patients in the drug arm. After 12 weeks the virus was undetectable for 78% of all treatment naïve patients taking setrobuvir in combination with pegylated interferon and ribavirin, while 76% of inadequate responders to current standards hit the same mark. The standard therapy-plus-placebo response was 56% and 44%, respectively.

"The antiviral response in patients who had failed prior treatment is a particularly encouraging benchmark of setrobuvir's potency and high barrier to resistance," said Anadys CEO Steve Worland. "Coupled with a favorable safety profile to date, we believe today's data position setrobuvir as a very attractive agent to be included in future DAA combination regimens."

That's all perfectly respectable data, but Anadys is likely to struggle when it comes to stirring much enthusiasm for the results as developers compete for attention in the field. Pharmasset has been stealing the headlines with a potential interferon-free approach--PSI-7977--that is at the mid-stage point of development. Analysts are paying keen attention to new oral treatments that will offer a much simpler regimen than Vertex's Incivek, which has been making quick inroads as an impressive new standard of treatment for hepatitis C. And Vertex has some plans of its own in that respect.

- here's the Anadys release
- see the report from Reuters

Suggested Articles

The FDA rejected CytoDyn’s application for its lead program, a treatment for HIV because it’s missing some information.

Dewpoint Therapeutics is teaming up with Merck to develop a new way to fight HIV using its molecular condensates platform.

The study linked SPK-8011 to improvements in factor VIII expression and bleeding out to 3.3 years, but it will be 2021 before phase 3 dosing begins.