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It's likely going to take a cocktail of drugs to fight hepatitis C, but you need only one from each class of drugs. Attacking the virus from multiple angles is the way to go.
So it's a good thing that Vertex Pharmaceuticals (Nasdaq: VRTX ) licensed two hepatitis C drugs from Alios BioPharma, because only one of them made it past the critical phase 1 clinical trial. Vertex is dropping development of ALS-2158 after it failed to produce enough antiviral activity to justify taking it further into the clinic.
The other drug that Vertex got in the deal, ALS-2200, which it's calling VX-135, looks much better. We already saw solid data from a phase 1 trial by itself, and yesterday Vertex followed that up with data from patients that took ALS-2200 with ribavirin, a generic antiviral drug. The median reduction in virus levels for the combination therapy wasn't quite as good as the group that got ALS-2200 alone, but the percent of patients reaching undetectable levels was slightly higher.
Of course, were talking about only eight patients. It's going to take a phase 2 and eventually a phase 3 trial to confirm that ALS-2200 works. Vertex plans to evaluate ALS-2200 in two phase 2 trials. One trial will combine it with ribavirin. And the other trial will combine ALS-2200 with Incivek, Vertex's approved hepatitis C.
ALS-2200 and ALS-2158 are nucs, which work by stopping the virus from replicating. The class was turned on its head last month when Bristol-Myers Squibb (NYSE: BMY ) stopped development of BMS-986094 because of safety issues. The FDA also put a pair of drugs from Idenix Pharmaceuticals (Nasdaq: IDIX ) on hold because they're related to Bristol's compounds. ALS-2200 appears to be different enough that the FDA isn't worried about its safety. I think Idenix's drugs eventually get off the hold, but the delay will help Vertex catch up.
It's unlikely ALS-2200 will be the first nuc on the market, though. Gilead Sciences (Nasdaq: GILD ) already has its nuc, GS-7977, in four phase 3 trials, which, if positive, would put the drug ready for FDA submission by the middle of next year.
Being second to market isn't ideal, but it might not be so bad if ALS-2200 has some safety, efficacy, or dosing advantage over GS-79777. We'll have to wait for the phase 2 data to see if that's the case.
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