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Dermata Completes Enrollment in First Pivotal DMT310 Phase 3 STAR-1 Clinical Trial for Acne
- STAR-1 topline results expected in March 2025 -- Over 30 million acne patients seek treatment in the U.S. each year -- Phase 2b for DMT310 achieved
About this update from Dermata Therapeutics, Inc.
[{"type":"text","content":"- STAR-1 topline results expected in March 2025 -- Over 30 million acne patients seek treatment in the U.S. each year -- Phase 2b for DMT310 achieved statistically significant results for all primary endpoints - SAN DIEGO, CA / ACCESSWIRE / December 3, 2024 / Dermata Therapeutics, Inc. (NASDAQ:DRMA)(NASDAQ:DRMAW) (\"Dermata\" or the \"Company\"), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions, today announced that it has successfully completed enrollment in its pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) study of DMT310, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. The STAR-1 study is the first of two Phase 3 studies that, if positive, would be used by Dermata to support the filing of a new drug application (NDA) for DMT310 for the treatment of moderate-to-severe acne. \"We are thrilled to complete enrollment in the STAR-1 study in less than a year,\" commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. \"I am proud of our team's persistence and efforts to complete study enrollment of this pivotal trial on schedule, thereby positioning the Company to receive the highly anticipated topline results in March 2025. We also want to express our sincerest appreciation to all patients and investigators who participated in this study as it would not be possible without them. We continue to be enthusiastic about DMT310 and its potential to be the first and only approved once-weekly, topical product for the treatment of moderate-to-severe acne. We believe patients continue to be disappointed with the slow onset of action of current treatments, while experiencing immediate tolerability issues, and we believe DMT310 could address these issues, creating a paradigm shift in the treatment of moderate-to-severe acne.\"DMT310 Phase 3 STAR-1 Clinical Study DesignThe DMT310 Phase 3 STAR-1 clinical study data will evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne. The STAR-1 study is a randomized (2:1), double-blind, and placebo-controlled study enrolling 520 patients with moderate-to-severe acne, ages 9 years and older in the United States and Latin America. The primary endpoints include the mean change from baseline in inflammat...