Benzinga | Nov 17, 2021 08:06AM EST

Dermata Therapeutics Reports First Patient Enrolled In Its Phase 2 Trial Of DMT310 For Treatment Of Moderate-To-Severe Rosacea

* Topline results expected in second half of 2022

* Rosacea affects about 16 million patients in the U.S.

SAN DIEGO, CA / ACCESSWIRE / November 17, 2021 / Dermata Therapeutics, Inc. ("Dermata," or the "Company") (NASDAQ:DRMA), a clinical-stage biotechnology company focused on the development of novel dermatology therapies for the medial and aesthetic markets, today announced it has enrolled the first patient in its Phase 2 trial of DMT310 for the once-weekly treatment of moderate-to-severe rosacea. DMT310 is Dermata's lead product candidate, consisting of a once-weekly topical treatment with both mechanical and chemical mechanisms of action, currently being investigated to treat multiple inflammatory skin conditions, including rosacea, acne, and psoriasis.

"We are excited to enroll the first patient in our Phase 2 trial of DMT310 for the treatment of moderate-to-severe rosacea and believe that due to the similarities between rosacea and acne we may see a similar reduction of inflammatory lesions in rosacea that we previously saw in our DMT310 Phase 2 acne trial," commented Christopher Nardo, Ph.D., Dermata's Senior Vice President of Development. "Additionally, based on in vitro data we have generated, DMT310 inhibits the production of IL-17, which we believe to be a cytokine that plays a role in the inflammatory pathway of rosacea. The downregulation of IL-17 coupled with the mechanical actions of DMT310's spicules could make DMT310, if approved, the first once-weekly topical product candidate to help treat the multiple symptoms of rosacea."

"This Phase 2 trial has the potential to reinforce the unique treatment effect of DMT310, and its ability to treat a variety of inflammatory skin conditions with once-weekly topical applications, unlike anything currently available on the market," stated Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "One of our core objectives at Dermata is to change how patients treat their skin conditions by providing them with unique and differentiated dermatology products in areas where there remains a high unmet need."

DMT310 Phase 2 Rosacea Trial Design

DMT310 Phase 2 rosacea trial is a 12-week, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the tolerability, safety and efficacy of once-weekly dosing of DMT310 in 180 moderate-to-severe rosacea patients. The primary endpoints include the mean change in inflammatory lesion counts and the Investigator's Global Assessment (IGA) using a 5-point scale, with IGA treatment success being defined as an IGA score of 'clear' or 'almost clear' and a 2-point improvement from baseline at week 12. Dermata expects to have topline results in the second half of 2022.