Enrollment of patients in DMT 310 phase III acne clinical program to begin in December 2023 based on agreement with FDA on the phase III protocols.-Dermata Therapeutics.
Dermata Therapeutics, Inc. a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, announces agreement with the FDA on the DMT 310 Phase III clinical protocols for the treatment of acne.
This agreement allows the Company to initiate the Phase III clinical trial program, with plans to begin enrolling patients in the first Phase III clinical trial in December 2023.
DMT 310 Phase III Clinical Trial Design: The DMT 310 Phase III clinical program will include two Phase III clinical trials to evaluate the efficacy, safety, and tolerability of DMT 310 in patients with moderate-to-severe facial acne. Each Phase III trial will be randomized (2:1), double-blind, and placebo-controlled, enrolling approximately 550 acne patients ages 9 years and older in the United States and Latin America. The primary endpoints are the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) response rate. IGA is measured on a 5-point scale (0-4), with a treatment response defined as a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Patients will be treated once weekly for 12 weeks with either DMT 310 or placebo and will be evaluated monthly. The first of two pivotal Phase III trials, STAR-1, is planned to begin enrolling patients by the end of 2023. If positive, the results from both Phase III clinical trials will be used to support the filing of an NDA with FDA.
Related news and insights
UCB announced that the European Commission (EC) has granted a marketing authorization for Zilbrysq (zilucoplan) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive
The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event (AE) data sources.
Pfizer Inc. announced topline data from the Phase II clinical trial (NCT04707313) investigating its oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes.