Dermira's DRM01 Phase 2a Trial Meets Primary Goals - Quick Facts

(RTTNews) - Dermira, Inc. (DERM), a specialty biopharmaceutical company, announced the presentation of clinical data from its successful DRM01 Phase 2a trial in patients with facial acne vulgaris.

The primary endpoints in this trial, the changes from baseline in inflammatory and non-inflammatory lesion counts and an improvement in the Investigator's Global Assessment or IGA of acne, were met with statistical significance.

This Phase 2a clinical trial was a randomized, multi-center, double-blind, vehicle-controlled study that enrolled 108 patients with moderate or severe acne.

Inclusion criteria required a minimum of 20 inflammatory lesions and 20 non-inflammatory lesions and an IGA score of three or greater on a five-point scale.

Patients were instructed to apply either DRM01 at a concentration of 7.5 percent or vehicle to the face twice daily for 12 weeks. A total of 53 subjects were randomized to receive DRM01, and the other 55 were randomized to receive vehicle only.

The primary efficacy endpoints consisted of absolute changes from baseline to week 12 in the numbers of inflammatory and non-inflammatory lesions and the proportion of patients with at least a two-grade improvement from baseline to week 12 in IGA score.

DRM01 was generally well tolerated with no reported serious treatment-related adverse events.

These results were presented during the Late-Breaking Research in Dermatology Forums at the American Academy of Dermatology Annual Meeting on March 20 in San Francisco. This was the first presentation of DRM01 data at a medical meeting.