This agreement allows the Company to initiate the Phase 3 clinical trial program, with plans to begin enrolling patients in the first Phase 3 clinical trial in
'Our team is thrilled to have received positive feedback and agreement from FDA to allow us to initiate the pivotal DMT310 Phase 3 clinical program, as this is an important milestone for Dermata,' said
DMT310 Phase 3 Clinical Trial Design
The DMT310 Phase 3 clinical program will include two Phase 3 clinical trials to evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne. Each Phase 3 trial will be randomized (2:1), double-blind, and placebo-controlled, enrolling approximately 550 acne patients ages 9 years and older in
About DMT310
DMT310 is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. It has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. DMT310 has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where DMT310 applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. DMT310 also observed almost 45% of patients achieve an IGA score of clear or almost clear compared with less than 18% of placebo patients achieving the same at the end of 12 weeks.
About Acne Vulgaris
Acne affects approximately 50 million people in the
About
Forward-Looking Statements
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: expectations with regard to the potential market acceptance of any of the Company's product candidates; timing of trials and data events; expectations with regard to the timing and/or results or responses from meetings with regulatory bodies, including the FDA; the success, cost, and timing of its product candidate DMT310 development activities and ongoing and planned clinical trials and whether the results of DMT310 will lead to future product development or approvals. These forward-looking statements are generally identified by the use of such words as 'may,' 'could,' 'should,' 'would,' 'believe,' 'anticipate,' 'forecast,' 'estimate,' 'expect,' 'intend,' 'plan,' 'continue,' 'outlook,' 'will,' 'potential' and similar statements of a future or forward-looking nature. 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
Contact:
Email: info@dermatarx.com
(C) 2023 Electronic News Publishing, source