Dermata Completes Enrollment in First Pivotal DMT310 Phase 3 STAR-1 Clinical Trial for Acne

Rhea-AI Summary

Dermata Therapeutics (NASDAQ:DRMA) has completed enrollment in its pivotal Phase 3 STAR-1 clinical trial for DMT310, a once-weekly topical treatment for moderate-to-severe acne. The study enrolled 520 patients aged 9 and older across the U.S. and Latin America, with topline results expected in March 2025. This randomized, double-blind, placebo-controlled study is the first of two Phase 3 trials needed to support an NDA filing. The trial will evaluate efficacy through inflammatory and noninflammatory lesion counts and Investigator Global Assessment scores over a 12-week treatment period.

Positive

• Successfully completed Phase 3 trial enrollment on schedule
• Previous Phase 2b achieved statistically significant results for all primary endpoints
• Large market opportunity with over 30 million U.S. acne patients seeking treatment annually
• Potential to be first approved once-weekly topical treatment for moderate-to-severe acne

Negative

• Topline results not available until March 2025
• Second Phase 3 trial still required before NDA submission
• FDA approval not guaranteed even with positive trial results

- 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 Design

The 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 inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response. 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 are treated once-a-week for 12 weeks with either DMT310 or placebo and are evaluated monthly. The STAR-1 study is the first of two pivotal Phase 3 studies, of which the second Phase 3 study will be followed by an extension study. If positive, the results from both Phase 3 studies would 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 achieving 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

Over 30 million acne patients in the U.S. seek treatment each year, 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.

About Dermata Therapeutics

Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions and diseases. The Company's lead product candidate, DMT310, is the first product candidate being developed from its Spongilla technology platform. DMT310 is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, DMT310 has been studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its DMT310 product as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin conditions and diseases. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: expectations with regard to the potential market acceptance of any of the Company's product candidates; timing of trials and data events; expectations with regard to the timing and/or results or responses from meetings with regulatory bodies, including the FDA; the success, cost, funds available, and timing of its product candidate DMT310 development activities and ongoing and planned clinical trials; and whether the results of DMT310 will lead to future product development or approvals. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com

SOURCE: Dermata Therapeutics

View the original press release on accesswire.com

FAQ

When will Dermata (DRMA) announce DMT310 Phase 3 STAR-1 trial results?

Dermata expects to announce topline results from the DMT310 Phase 3 STAR-1 trial in March 2025.

How many patients were enrolled in DRMA's Phase 3 STAR-1 acne trial?

The Phase 3 STAR-1 trial enrolled 520 patients with moderate-to-severe acne, ages 9 years and older.

What are the primary endpoints for Dermata's (DRMA) DMT310 Phase 3 trial?

The primary endpoints include mean change in inflammatory and noninflammatory lesion counts, and Investigator Global Assessment treatment response with at least a 2-point improvement.

How frequently is DMT310 administered in DRMA's Phase 3 trial?

DMT310 is administered once-weekly over a 12-week treatment period.