Dermira Initiates Phase 3 Clinical Program in Acne

On Jan 4, 2017

Dermira, Inc., a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, today announced dosing of the first patients in the Phase 3 program evaluating the safety and efficacy of olumacostat glasaretil (formerly DRM01), a novel, small molecule designed to reduce sebum production following topical application, in patients with acne vulgaris.

“Acne is a highly prevalent skin condition that negatively affects millions of people of all ages,” said Luis Peña, chief development officer of Dermira. “Despite the treatment options currently available, many people are still seeking new therapies that are safe, effective and well tolerated. The start of the olumacostat glasaretil Phase 3 clinical program is an important milestone for Dermira and puts us one step closer to potentially offering patients a new, topical treatment option that targets an underlying cause of acne that is not addressed by available topical therapies.”

Olumacostat Glasaretil Phase 3 Program
The Phase 3 clinical program consists of 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 and instructed to apply either olumacostat glasaretil at a concentration of 5.0% or vehicle, in a 2:1 fashion, twice daily to the face for 12 weeks.

At the recommendation of the FDA, one of the Phase 3 trials will also allow patients to apply olumacostat glasaretil or vehicle to acne-affected areas on the chest, back or shoulders. This is intended to provide additional safety data on the potential real-world use of olumacostat glasaretil. No efficacy endpoints will be measured on these areas.

Consistent with the two earlier Phase 2 trials, inclusion criteria require a minimum of 20 inflammatory lesions and 20 non-inflammatory lesions and an Investigator’s Global Assessment (IGA) score of three or four on a five-point scale that ranges from a score of zero, representing clear skin, to a score of four, representing severe disease. The primary endpoints of both trials will evaluate the absolute changes from baseline in inflammatory and non-inflammatory lesion counts on the face and the proportion of patients achieving at least a two-grade improvement and a grade of 0 or 1 from baseline on the five-point IGA scale. Secondary endpoints will evaluate the percentage change from baseline in inflammatory and non-inflammatory lesion counts on the face and the proportion of patients achieving at least a two-grade improvement on the five-point IGA scale from baseline. All efficacy endpoints will be measured at the end of the 12-week treatment period. Safety will also be assessed.

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

Topline results from CLAREOS-1 and CLAREOS-2 are expected in the first half of 2018.