- 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.
DMT310 is Dermata's lead product candidate which incorporates the proprietary, multifaceted, Spongilla technology to topically treat a variety of dermatological conditions. DMT310 is a multifactorial, naturally derived product candidate from a unique freshwater sponge that is harvested under specific environmental conditions and then processed into a powder. The powder is then mixed with a fluidizing agent immediately prior to its once-weekly application. The powder contains needle-like spicules that mechanically act to stimulate collagen production and create micro-channels in the skin, allowing for the penetration of chemical compounds. In addition to its mechanical components, DMT310's organic material contains chemical compounds that when tested in vitro, have shown a dose dependent inhibition of both IL-17A and IL-17F, which are believed to be major effector cytokines in the inflammatory pathway of rosacea.
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 the 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 conditions. 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 product candidate DMT310; the progress of patient enrollment and dosing in the Company's clinical trials; the ability of the Company's product candidates to achieve applicable endpoints in the clinical trials; whether the results of DMT310 will lead to future product development; the timing of when future clinical results of DMT310 will be announced; 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