Olumacostat Glasaretil (formerly DRM01)

Re-considering a therapeutic path for acne vulgaris.

Olumacostat glasaretil is a novel, small molecule currently in Phase 3 development for the treatment of acne vulgaris that is designed to target sebum production, following topical application. Sebum is an oily substance made up of lipids produced by glands in the skin called sebaceous glands.

Excessive sebum production is an important factor in the development of acne that is not addressed by available topical therapies.

Specifically targeting excessive sebum production.

Olumacostat glasaretil is thought to have a differentiated mechanism of action. It is designed to exert its effect by inhibiting acetyl coenzyme-A carboxylase, an enzyme that plays an important role in the synthesis of more than 80 percent of the lipids that make up sebum.

Topline results from a Phase 2b dose-ranging clinical trial in adult patients 18 and older with moderate-to-severe facial acne vulgaris have been reported.

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.

The Phase 3 program also includes an open-label study, CLARITUDE, assessing the long-term safety of olumacostat glasaretil, in which approximately 700 patients from either of the two Phase 3 studies will be permitted to continue to receive treatment for up to an additional 36 weeks.

If approved, olumacostat glasaretil would be the first topical treatment for acne to specifically target excessive sebum production.