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Dermata Therapeutics Announces Positive Feedback from FDA on the DMT310 Phase 3 Clinical Development Program in Moderate-to-Severe Acne
- FDA established key elements of the DMT310 Phase 3 clinical program and delineated a potential regulatory pathway for approval of DMT310 --The DMT310 Phase
About this update from Dermata Therapeutics, Inc.
[{"type":"text","content":"- FDA established key elements of the DMT310 Phase 3 clinical program and delineated a potential regulatory pathway for approval of DMT310 --The DMT310 Phase 3 program will consist of two pivotal trials, STAR-1 and STAR-2 (Spongilla Treatment of Acne Research Study)-- The first patient in STAR-1 is planned to be enrolled in 2H of 2023 -SAN DIEGO, CA / ACCESSWIRE / June 27, 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 announced that following the Company's receipt of FDA responses to its End of Phase 2 meeting package, the Company's DMT310 Phase 3 clinical development program for the once-weekly topical treatment of patients with moderate-to-severe acne is on track to begin in the second half of 2023. The Company submitted data from its Phase 1 and 2 clinical trials, as well as a nonclinical data package supporting the efficacy, safety, and tolerability of DMT310 for the treatment of moderate-to-severe acne for its Phase 3 clinical development program.FDA provided written responses to the Company's End of Phase 2 meeting package including an agreement that the Company's (1) nonclinical program appears reasonable to support Phase 3 clinical trials, (2) the overall Phase 3 clinical development program appears acceptable for filing a New Drug Application (NDA), (3) the three co-primary endpoints and secondary endpoints proposed in the Phase 3 clinical trial protocols are acceptable, and (4) the completed and planned nonclinical studies would be sufficient to support the submission of an NDA. Additionally, at the recommendation of FDA, the Company has agreed to include additional safety evaluations (laboratory measurements, electrocardiograms, and an extension study) in the Phase 3 clinical program and plans to submit final updated protocols to FDA shortly.Based on FDA's feedback, the Company anticipates that the Phase 3 clinical program will consist of two independent pivotal trials and an extension study. Each pivotal trial will evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne. Both pivotal Phase 3 trials will be randomized (2:1), double-blind, and placebo-controlled. The primary endpoints will include the mean change fro...