Business
Dermata Announces Achievement of 50% Enrollment in Pivotal DMT310 Phase 3 STAR-1 Clinical Trial for Acne
- STAR-1 topline results expected in first quarter of 2025 -- About 30 million acne patients seek treatment in the U.S. each year -- DMT310, if approved,
About this update from Dermata Therapeutics, Inc.
[{"type":"text","content":"- STAR-1 topline results expected in first quarter of 2025 -- About 30 million acne patients seek treatment in the U.S. each year -- DMT310, if approved, could be the first once-weekly topical product for the treatment of acne - SAN DIEGO, CA / ACCESSWIRE / July 17, 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 conditions, today announced that it has successfully enrolled 50% of patients 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 the Company to support the filing of a new drug application (NDA) for DMT310 for the treatment of moderate-to-severe acne.\"We are excited by the enrollment progress seen in the STAR-1 study since enrolling our first patient in December 2023 and want to thank all those patients for their participation in the study,\" said Christopher Nardo, Ph.D., Dermata's Chief Development Officer. \"With all clinical sites activated, we expect to continue our enrollment momentum in the coming months and expect to announce topline data from the STAR-1 study in the first quarter of 2025,\" Dr. Nardo continued. \"Investigators continue to be enthusiastic about DMT310 and its potential to be the first approved once-weekly, topical product for the treatment of moderate-to-severe acne as there continues to be a need for safe and effective treatment options. We believe that if the DMT310 Phase 3 program confirms the safety and efficacy observed in our Phase 2b acne study, that if approved, DMT310 could become a first line therapy for the treatment of moderate-to-severe acne,\" concluded Dr. Nardo.DMT310 Phase 3 Clinical Program DesignThe DMT310 Phase 3 clinical program will include two Phase 3 clinical trials to evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne. Each Phase 3 trial will be randomized (2:1), double-blind, and placebo-controlled, enrolling approximately 550 patients with moderate-to-severe acne, ages 9 years and older in the United States and Latin America. The primary endpoints are the mean ch...