Dermata招募第一名患者参加Pival DMZ 310三期STAR-1痤疮临床试验;约550名患者将每周接受一次治疗，持续12周

- About 550 patients will be treated once weekly for 12 weeks -
- STAR-1 topline results expected in first quarter of 2025 -
- Acne affects about 50 million patients in the U.S. -

SAN DIEGO, CA / ACCESSWIRE / December 20, 2023 / Dermata Therapeutics, Inc. (NASDAQ:DRMA, DRMAW))))) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced that it successfully enrolled the first patient in its pivotal DMT310 Phase 3 Spongilla Treatment for Acne Research (STAR-1) study. The STAR-1 study is the first of two Phase 3 studies that, if positive, will 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.

"Getting the first patient enrolled in this Phase 3 program is an important step in the potential approval of DMT310 as a first in class treatment for the millions of patients suffering from acne," said Christopher Nardo, Ph.D., Dermata's Chief Development Officer. "DMT310 has demonstrated significant improvement for both inflammatory and noninflammatory facial lesions in our Phase 2b study, and we are excited to attempt to confirm this efficacy in the pivotal Phase 3 clinical program. We look forward to providing additional updates on the progress of this program and anticipate topline results from the STAR-1 study in early 2025."

DMT310 Phase 3 Clinical Trial Design

The 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 change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response rate. IGA is measured on a 5-point scale (0-4), with a treatment response defined as at least a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Patients will be treated once a week for 12 weeks with either DMT310 or placebo and will be evaluated monthly. STAR-1 is the first of two pivotal Phase 3 trials, which will be followed by a long-term extension study. If positive, the results from both Phase 3 clinical trials will be used to support the filing of an NDA with FDA.

About DMT310

DMT310 is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. DMT310 has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. DMT310 has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where DMT310 applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. DMT310 also observed almost 45% of patients achieve an IGA score of clear or almost clear compared with less than 18% of placebo patients achieving the same at the end of 12 weeks.

About Acne Vulgaris

Acne affects approximately 50 million people in the U.S., with about 85% of teenagers experiencing some form of acne, and some individuals suffering from acne well into their 30s, 40s, and beyond. Acne is characterized by areas of scaly red skin, noninflammatory blackheads and whiteheads, inflammatory papules and pustules, and occasionally cysts and scarring, which can present on the face, neck, chest, back, shoulders, and upper arms. While not life-threatening, acne can cause significant trauma for those suffering from it due to social stigmas, substantial risk of permanent facial scarring, lowered self-esteem, and social withdrawal.