- Topline results expected in the second half of 2022 -
- Rosacea affects about 16 million patients in the U.S. -
SAN DIEGO, CA / ACCESSWIRE / June 13, 2022 / Dermata Therapeutics, Inc. ("Dermata," or the "Company") (NASDAQ:DRMA), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced it has completed enrollment of 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, utilizing both mechanical and chemical mechanisms of action. DMT310 is currently being investigated to treat multiple inflammatory skin conditions, including rosacea, acne, and psoriasis.
"Completing enrollment of the Phase 2 DMT310 rosacea study is a big step for us as we continue to develop DMT310 as an innovative treatment option for multiple inflammatory skin diseases," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "We believe that the similarities between rosacea and acne may lead to a similar reduction of inflammatory lesions in rosacea as we saw in our DMT310 Phase 2 acne trial, where acne patients treated with DMT310 experienced a 62% reduction in inflammatory lesions at week 12," continued Mr. Proehl. "If DMT310 is approved for the treatment of moderate-to-severe rosacea, it could be the first once-weekly topical product to help treat the inflammatory lesions of rosacea. We look forward to announcing the topline results in the second half of 2022," concluded Mr. Proehl.
DMT310-005 Phase 2 Trial Design
DMT310-005 is a 12-week, multi-center, randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate the efficacy, safety, and tolerability of once-weekly dosing of DMT310 in 180 moderate-to-severe rosacea patients. The primary endpoints include the mean change in inflammatory lesion counts (the number of papules and pustules on the face) and the Investigator's Global Assessment (IGA) of disease severity using a 5-point scale, with treatment success being defined as an IGA score of ‘clear' or ‘almost clear' and a 2-grade improvement from baseline at week 12.
DMT310 is Dermata's lead product candidate and incorporates the Company's proprietary Spongilla technology to topically treat a variety of dermatological conditions, including acne, rosacea, and psoriasis. DMT310 is a multifactorial, naturally derived product candidate from Spongilla lacustris, a unique freshwater sponge that is harvested under specific environmental conditions and then processed into a powder. The powder is mixed with a fluidizing agent immediately prior to its once-weekly application. In addition to its mechanical components which create microchannels into the dermis and promote skin turnover, DMT310's organic components contain chemical compounds that when tested in vitro have shown a dose dependent inhibition of both IL-17A and IL-17F, which are believed to play a role in the inflammatory pathway of rosacea.
About Dermata Therapeutics
Dermata Therapeutics, Inc. is a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions. The Company's lead product candidate, DMT310, is its first product candidate being developed from its Spongilla technology platform. DMT310 is under clinical development for the treatment of acne, psoriasis, and rosacea. Dermata's second product candidate, DMT410, uses its Spongilla technology as a new method for topical intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin indications. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: the potential development and commercialization of DMT310; the ability of the Company's product candidates to achieve applicable endpoints in clinical trials; whether the interpretation of the results of DMT310 will lead to future product development; the safety and tolerability profile of DMT310; the timing of when additional studies in rosacea may occur, if any; the design of additional studies to be conducted; and whether the Company will have the ability to obtain adequate funding for future development of its product candidates. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
Senior Director, Legal and Business Development
SOURCE: Dermata Therapeutics