SAN FRANCISCO – An investigational topical sebum inhibitor met its primary endpoints in a phase IIa trial, significantly reducing inflammatory and noninflammatory lesions in patients with facial acne vulgaris, researchers reported at the annual meeting of the American Academy of Dermatology.
“This study demonstrated that DRM01, belonging to a novel class of topical acne therapeutic agents, is well tolerated and shows evidence of efficacy for treatment of facial acne vulgaris,” said Dr. Robert Bissonnette of Innovaderm Research. Patients had no serious adverse events related to treatment, although the topical product caused erythema at the application site, he said.
The DRM01 agent inhibits sebum production by competing with acetyl coenzyme A carboxylase, which facilitates the first and rate-limiting step in fatty acid synthesis. “It has shown pronounced impact on triacylglycerols, which are considered the most important component of sebum in acne vulgaris,” said Dr. Bissonnette.
The researchers randomized 108 patients with moderate to severe facial acne to 12 weeks of twice-daily treatment with either 7.5% DRM01 or the vehicle gel. On average, patients had 29 inflammatory lesions and 40 noninflammatory lesions at baseline, and approximately two-thirds were women.
At week 12, the DRM01 group had an average 63.9% reduction in inflammatory lesions, compared with 45.9% for the vehicle control group (P < .001), Dr. Bissonnette said. The DRM01 group also had a 48.1% reduction in non-inflammatory lesions, compared with 28.8% for the control group (P =.003). Furthermore, 24.5% of patients who received DRM01 improved by at least two grades on the Investigator’s Global Assessment score, compared with only 7.3% of the control group (P = .007).
Most adverse events were mild or moderate and affected similar proportions of patients in each group, said Dr. Bissonnette. More than 5% of patients in both groups experienced application site dryness, burning, and stinging, but only patients in the treatment group reported application site erythema, he said. Nasopharyngitis affected 24.5% of patients treated with DRM01 and 12.7% of those treated with the vehicle, but was considered unrelated to treatment.
Researchers do not know how or whether DRM01 reduces inflammation, Dr. Bissonnette said in response to a question from an audience member. The study also was not able to show that DRM01 significantly reduced sebum production compared with the gel vehicle. “It could be a data quality problem, as the sites had not all been fully trained in doing those measurements,” he said.
Dermira manufactures DRM01 and sponsored the study. Dr. Bissonnette reported having served as a researcher for Dermira.