Dermira’s facial acne vulgaris study of DRM01 shows improvement in all endpoints

DRM01 is a novel, small molecule designed to inhibit sebum production after topical application to treat acne.

It is designed to target acetyl coenzyme-A carboxylase, an enzyme that plays a key role in the synthesis of fatty acids, which are an essential component of sebum.

The double-blind, parallel group study enrolled 420 subjects across 34 sites in the US and Canada.

DRM01 showed statistically significant enhancements from baseline to week 12 relative to vehicle in all primary efficacy endpoints at the highest dose of 7.5% twice daily.

It also demonstrated the highest efficacy in all primary endpoints compared to the two lower doses.

The average reduction in inflammatory lesions was 15.0 compared to 10.7 for combined vehicle (p=0.001) or an average reduction of 55.6% versus 40.0% (p<0.001).

The average reductions in non-inflammatory lesions in the two groups were 17.5 and 9.3, respectively (p<0.001) or average reductions of 47.8% and 28.7% (p<0.001).

Dermira chairman and CEO Tom Wiggans said: "Each of the doses we evaluated demonstrated results that we believe could support their advancement into a Phase 3 program.

"We are encouraged by the potential of this molecule to target the underlying cause of acne following topical application. Our goal is to provide a transformative treatment option for the millions of people coping with acne and its impact on their quality of life."

Based on these results, Dermira aims to start a phase 3 program to assess the safety and efficacy of DRM01 as a potential treatment for acne in adult and adolescent patients.

The program is expected to start in the first half of next year, subject to an end-of-Phase 2 meeting with the US Food and Drug Administration.