- Janssen, a subsidiary of pharma giant Johnson & Johnson, plans to advance an experimental triple-combo hepatitis C drug into Phase 2b testing after new interim results showed the regimen led to 100% cure rates in three patient cohorts.
- Notably, treatment with a combination of odalsavir, AL-335 and Olysio (simeprevir) led to sustained virologic responses after eight weeks of treatment among all 40 patients in two cohorts, according to results announced by J&J partner Achillion Pharmaceuticals Friday morning.
- Drugs from market leader Gilead boast similarly high cure rates, but do so in eight to 12 weeks. Gilead's revenues from Harvoni have fallen sharply in the U.S. as fewer uncured patients are left to initiate treatment.
Janssen tested the triple-combo drug cocktail in three patient cohorts, along with another cohort given just odalsavir and AL-335. All 60 patients in the three cohorts given the triple combo were cured of the liver disease. Two patients in the fourth cohort treated with the doublet saw viral rebound after treatment, however.
Although the hepatitis C market is fairly mature, with existing drugs effectively curing many patients, there is competition to offer treatment regimens with shorter durations. Gilead is also testing a triple-combo drug with an eight-week dosing regimen.
In light of the trial results, Janssen plans to test a combination of odalasvir 25mg, AL-335 800mg and simeprevir 75mg in a future Phase 2b trial.
"Based on two viral rebounds observed in the eight week dual NS5A arm, we have confirmed that [Achillion/J&J] will no longer pursue a dual-regimen — slightly disappointing," wrote Jefferies equity analyst Brian Abrahams in an investor note.
Abrahams saw potential for Johnson & Johnson to compete with Gilead provided further data shows continued high efficacy rates.
A six-week course of treatment for the triple combo led to hepatitis C virus RNA-negative results (or below the level of quantitation at end of treatment) in all 20 patients enrolled in that cohort.
Most adverse results were mild, but one patient did experience an asymptomatic second degree atrioventricular block related to treatment. Jefferies Abrahams' noted safety standards for new hep C drugs are likely to be very high, given existing treatment options.