J&J, Gilead combo quells hep C in 100% of PhII cohort
Medivir has posted a stellar snapshot of interim data from its Phase IIa study of a combo hepatitis C treatment that adds Gilead's hot property--GS-7977--with the Swedish biotech's simeprevir (TMC435), which is partnered with Johnson & Johnson ($JNJ).
The combo therapy cleared the virus in 100% of the genotype 1 patients--divvied into four treatment groups-- who could be evaluated on an interim basis. A total of 80 patients were in the cohort, though not all could be evaluated for this interim picture. All of the patients were "null-responder" hepatitis C patients with mild to moderate fibrosis. And the clear rate was the same for patients receiving 12 weeks and 24 weeks of therapy, with or without ribavirin. There were no reported incidents of serious adverse events.
Simeprevir--an NS3/4A protease inhibitor--combined with interferon is already in late-stage studies for hep C. But the developers, and the broad industry, is paying closer attention to next-gen drugs that dispense with interferon, a treatment associated with lingering flu-like symptoms which can often force patients to go off therapy. In the second cohort of the Phase IIa, investigators are testing the combo in a group of treatment-naïve patients, a growing market as more doctors and patients wait for a new approach.
Combo hep C drug studies have become a virtual cottage industry in the biopharma field.
In addition to its combo study with Gilead's ($GILD) nuc, 7977, there's a Phase II study with Bristol-Myers Squibb's ($BMY) NS5A replication complex inhibitor daclatasvir (BMS-790052) in treatment-naïve and previous null-responder genotype 1 HCV patients. Another mid-stage study that matches simeprevir with Janssen's non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naïve genotype 1a and 1b HCV patients is in progress. And the drug is also being studied alongside Vertex's ($VRTX) drug hopeful, VX-135.
Gilead is already finished with an ambitious late-stage program for 7977, which it acquired in the controversial $11 billion acquisition of Pharmasset. That's put Gilead on a short path to a possible approval, but you can expect plenty of additional work in search of cocktails that are even more effective at quelling the virus in a brief period of time among various disease groups.
- here's the press release