Biotech Values

[DewDiligence]

MRK tries qD Isentress again; this time, the qD dose is 1200mg, 50% higher than the cumulative daily dose of regular (BID) Isentress:

http://finance.yahoo.com/news/first-patient-enrolled-phase-3-210000738.html

The ONCEMRK trial is a multicenter, double-blind, randomized, active-controlled study evaluating the safety, efficacy, tolerability and pharmacokinetics of reformulated raltegravir 1200 mg (dosed as two 600 mg tablets) once daily, compared with ISENTRESS 400 mg twice daily, both in combination with once-daily tenofovir/emtricitabine [i.e. Truvada] over 96 weeks. The primary endpoint of the non-inferiority study is the proportion of patients achieving viral suppression [at 48 weeks]…

The trial is enrolling 750 treatment-naïve patients randomized 1:1; the expected completion date for the primary endpoint is Apr 2016 (http://www.clinicaltrials.gov/ct2/show/NCT02131233 ).

In MRK’s prior failed phase-3 trial of qD Isentress, the qD dose was 800mg, the same as the cumulative daily BID dose (#msg-57170320).

p.s. That Isentress continues to sell at a $1.6B annualized rate despite competition from GILD’s Stribild is impressive.