Bristol-Myers reports interferon-free cures in small PhII hep C study

While Bristol-Myers Squibb ($BMY) was dealt a setback today on the diabetes front, investigators were reporting progress with a new combination approach to hepatitis C that's raising hopes for an interferon-free approach to treating hepatitis C. In a small Phase II study, four of 11 patients who hadn't responded to standard therapy and were treated only with the experimental antivirals daclatasvir and asunaprevir were effectively cured of hepatitis C. And the four included both of the patients with the HCV genotype 1b.

"This study was the first study to demonstrate the possibility that hepatitis C can be cured (defined as sustained virologic response 48 weeks post-treatment or SVR48) without the use of interferon," BMS reported. "The study also demonstrated that 100 percent (10 out of 10) of these difficult-to-treat patients dosed with quadruple therapy containing daclatasvir and asunaprevir in combination with PEG-Interferon alfa and ribavirin achieved" a cure.

Finding a way to cure hepatitis C with an oral combination regimen that excludes interferon--a therapy commonly linked to fatigue and flu symptoms--has become one of the Holy Grails of biotechnology. That quest inspired BMS to pay $2.5 billion for Inhibitex ($INHX) as rivals compete to conquer a rapidly growing market.

Of course, with only a handful of patients in the Phase II study BMS still has a long ways to go before it offers pivotal data. But with proof of principle data in hand, it just leaped forward in the race to the FDA.

- read the press release
- here's the Bloomberg report

Suggested Articles

Californian RNA biotech Arrowhead will lose its COO and R&D head from next year but is hiring a new CMO and CSO to help steady its research exec team.

The biotech began testing the small molecule in a phase 3 trial of heavily pretreated small cell lung cancer patients late last year. 

Roche is spending up to $1.4 billion to snap up a scarring-focused biotech, nabbing an FDA breakthrough-tagged therapy in the process.