Dermira presents positive clinical data from DRMO1 phase 2a trial

Dermira recently announced its DRMO1 phase 2a trial has met the study’s primary efficacy endpoints in patients with facial acne vulgaris.

The company presented the statistically significant clinical data for the first time at the American Academy of Dermatology Annual Meeting, according to a company press release.

The randomized, multicenter, double-blind, vehicle-controlled study evaluated 108 patients with moderate-to-severe acne during a 12-week span. DRMO1 - a novel, topical, small-molecule sebum inhibitor - was administered to 53 patients at a concentration of 7.5%, whereas 55 patients were randomly assigned to receive vehicle only. The study’s primary efficacy endpoints were the absolute changes in inflammatory and noninflammatory lesions from baseline to week 12, and the proportion of patients who demonstrated at least a two-grade improvement in Investigator’s Global Assessment (IGA) of acne score from baseline to week 12.

The number of inflammatory lesions was reduced by 63.9% in those treated with DRMO1 compared with a reduction of 45.9% in patients who received the vehicle only, and the number of noninflammatory lesions was reduced by 48.1% in DRMO1-treated patients compared with 28.8% in vehicle-only treated patients.

After 12 weeks, 24.5% of the patients who received DRMO1 achieved a successful improvement in the Investigator’s Global Assessment of acne compared with 7.3% of patients who received the vehicle only, according to the release.

DRMO1 was generally well-tolerated with no treatment-related serious adverse events reported.

The company plans to initiate a dose-finding phase 2b clinical study with DRM01 in the near future, according to the release.

Reference: www.dermira.com.