Dermata Therapeutics, Inc. announced that positive results from its DMT310 Phase 2b study of its once-weekly topical treatment in patients with moderate-to-severe acne vulgaris was published in the prestigious, peer-reviewed Journal of the American Academy of Dermatology (JAAD) and can by found at this link. The study found that once-weekly topical treatment with DMT310 resulted in significant improvements across multiple efficacy endpoints at 12 weeks in patients with moderate-to -severe acne when compared with placebo. DMT310 Phase 2b Trial Design: The DMT310 Phase 2b randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy, safety, and tolerability of DMT310 applied once-weekly in 181 participants 12 years of age and older with moderate-to-severe facial acne.

Participants were randomized in a 1:1 ratio to receive either DMT310 mixed with 6 ml of 3% hydrogen peroxide or placebo mixed with 6 ml of 3% hydrogen peroxide. The assigned study drug was applied to the entire face once-weekly for 12 weeks. DMT310 Phase 2b Key Findings: All primary and secondary efficacy endpoints were met.

DMT310 demonstrated statistically significant reductions in inflammatory (-15.6 vs. -10.8, p < 0.01) and noninflammatory (-18.3 vs. -12.4, p < 0.01) lesion counts at week 12 when compared to placebo.

Notably, DMT310 patients experienced an early statistically significant effect in the percent reductions from baseline in inflammatory (-45.2% vs. -23.8%, p < 0.001) and noninflammatory (-36.4% vs. -14.3%, p < 0.001) lesion counts at week 4 when compared to placebo.

DMT310 also demonstrated statistically significant improvements in IGA at all time points with a responder defined as having a 2-grade change and an IGA score of 0 (clear) or 1 (almost clear). DMT310 appeared to be safe and well tolerated with no drug-related serious adverse events reported during the 12-week study.