Business
Dermata Therapeutics Provides Corporate Update and Reports Full Year 2022 Financial Results
- End of Phase 2 meeting with FDA for DMT310 for moderate-to-severe acne expected in 2Q 2023 -- Initiation of DMT310 Phase 3 clinical trial program in
About this update from Dermata Therapeutics, Inc.
[{"type":"text","content":"- End of Phase 2 meeting with FDA for DMT310 for moderate-to-severe acne expected in 2Q 2023 -- Initiation of DMT310 Phase 3 clinical trial program in moderate-to-severe acne patients expected in 2H 2023 -- DMT410 partnering discussions ongoing -SAN DIEGO, CA / ACCESSWIRE / February 21, 2023 / Dermata Therapeutics, Inc. (Nasdaq:DRMA; DRMAW) (\"Dermata,\" or the \"Company\"), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today highlighted recent corporate progress, and reported financial results for the year ended December 31, 2022.\"We are very excited for what Dermata has planned for 2023 for both our DMT310 and DMT410 programs,\" said Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. \"We believe advancing the DMT310 acne program into Phase 3 will be a significant step for our company. I am confident that our team can continue forward progress and build upon the results we saw in our positive DMT310 Phase 2b acne study,in which almost 45% of patients achieved an investigator global assessment, or IGA, score of ‘clear' or ‘almost clear' at the end of the 12-week clinical study. We are also encouraged by the progress made to further develop DMT410 as a potential method to topically deliver botulinum toxin for hyperhidrosis and aesthetic skin conditions.\"Anticipated Upcoming MilestonesType C Meeting Request with FDA on DMT310 Chemistry, Manufacturing, and Controls (CMC) questions. Dermata has submitted a Type C meeting request to FDA with questions in order to receive feedback related to the CMC of DMT310 for Phase 3 and, if successful, a new drug application, or NDA, to FDA. The company expects to receive feedback from FDA in 1H 2023.DMT310 End of Phase 2 Meeting with FDA. Dermata plans to request an end of Phase 2 meeting with FDA in 2Q 2023. Feedback from FDA will help guide Dermata's design of its DMT310 Phase 3 clinical trial program in moderate-to-severe acne patients.DMT310 Phase 3 Program in Moderate-to-Severe Acne. After receiving feedback from the end of Phase 2 meeting with FDA, the Company intends to initiate its DMT310 Phase 3 clinical trial acne program in 2H 2023. If the Phase 3 program is successful, the Company intends to submit an NDA to FDA seeking regulatory approval of DMT310 for moderate-to-severe acne.DMT410 Partnership Di...