Dermata Announces Receipt of Type C Meeting Response from the FDA and Submission of DMT310 End of Phase 2 Meeting Package
Dermata Therapeutics (NASDAQ:DRMA, DRMAW) announced significant progress in its development of DMT310, a treatment for moderate-to-severe acne. The FDA has acknowledged that Dermata's Chemistry, Manufacturing, and Controls (CMC) procedures are adequate for initiating Phase 3 studies. Furthermore, the company submitted an end of Phase 2 meeting package to discuss clinical requirements with the FDA. Dermata anticipates receiving feedback on this package by the end of June 2023 and plans to begin Phase 3 trials in the second half of 2023. Upon successful completion of these trials, the company may proceed with a new drug application for DMT310.
- FDA approval of CMC procedures supports initiation of Phase 3 studies.
- Submission of end of Phase 2 meeting package to discuss advancement of DMT310.
- Anticipation of FDA feedback by June 2023, leading to potential Phase 3 trials in H2 2023.
- None.
- FDA agrees that Dermata's CMC procedures and controls support the initiation of Phase 3 studies-
- Dermata also submitted an end of phase 2 meeting package to the FDA -
SAN DIEGO, CA / ACCESSWIRE / April 20, 2023 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) ("Dermata" or the "Company"), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced that it has received a response from the U.S. Food and Drug Administration ("FDA") to the Company's Type C Chemistry, Manufacturing, and Controls ("CMC") meeting request. The FDA's response stated that the Company has provided documentation of its CMC procedures and controls sufficient to support the initiation of Phase 3 studies. The Company has also submitted an end of phase 2 meeting package to the FDA to discuss clinical requirements to advance DMT310 into Phase 3 development as a treatment for moderate-to-severe acne. The Company expects to receive written feedback on the end of phase 2 meeting package from the FDA by the end of June 2023. Upon agreement with the FDA, the Company plans to initiate the Phase 3 program for acne in the second half of 2023. If the Company is able to successfully complete the Phase 3 program, it believes the results could support submission of a new drug application for DMT310 for the treatment of moderate-to-severe acne.
About Dermata Therapeutics
Dermata Therapeutics 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 a once-weekly topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, DMT310 has been studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its Spongilla technology as a new method for needle-free 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/.
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 data events; expectations with regard to the timing and/or results from meetings with regulatory bodies, including the FDA; expectations with regard to any potential partnership opportunities for the Company's product candidates; 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 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.
Investors:
Sean Proehl
Senior Director, Legal and Business Development
info@dermatarx.com
SOURCE: Dermata Therapeutics
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FAQ
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