Under evaluation in Phase 3 clinical program.
In January 2017, Dermira announced that the first patients were dosed in a Phase 3 clinical program evaluating the safety and efficacy of olumacostat glasaretil in patients with acne vulgaris. The Phase 3 clinical program includes two randomized, multi-center, double-blind, parallel-group, vehicle-controlled trials, CLAREOS-1 and CLAREOS-2, designed to assess the safety and efficacy of olumacostat glasaretil compared to vehicle to support a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). The program is expected to enroll a total of approximately 1,400 patients ages nine and older with moderate-to-severe acne vulgaris at approximately 100 sites in the United States, Canada and Australia. In each trial, approximately 700 patients will be randomized in a 2:1 fashion and instructed to apply either olumacostat glasaretil or vehicle, in a 2:1 fashion, twice daily to the face for 12 weeks. Topline results from the Phase 3 safety and efficacy trials are expected in the first half of 2018.