Dermata Announces that Last Patient Completes Last Visit in Pivotal XYNGARI™ Phase 3 STAR-1 Clinical Trial for Acne

Rhea-AI Summary

Dermata Therapeutics (NASDAQ: DRMA) has announced the completion of the last patient visit in their pivotal Phase 3 STAR-1 clinical trial for XYNGARI™, a novel once-weekly topical treatment for moderate-to-severe acne. The trial enrolled 520 patients across the U.S. and Latin America, with topline results expected by end of March 2025.

The STAR-1 study is a randomized (2:1), double-blind, placebo-controlled trial evaluating XYNGARI's efficacy, safety, and tolerability. Primary endpoints include changes in inflammatory and noninflammatory lesion counts and Investigator Global Assessment (IGA) treatment response. The treatment period lasted 12 weeks, with monthly evaluations.

XYNGARI™ targets multiple acne mechanisms, including inflammation reduction and pore unclogging. With over 30 million acne patients seeking treatment annually in the U.S., this represents the first of two pivotal Phase 3 studies required for FDA new drug application submission.

Positive

• Large market opportunity with 30M+ annual U.S. acne patients
• Phase 3 trial completed on schedule
• Novel once-weekly dosing vs traditional daily treatments
• Multiple mechanisms of action targeting root causes of acne

Negative

• Results still pending - no efficacy data available yet
• Second Phase 3 trial still required for FDA approval
• Will need to demonstrate superiority over existing treatments

News Market Reaction

-3.58%

1 alert

-3.58% News Effect

On the day this news was published, DRMA declined 3.58%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

- STAR-1 topline results expected by the end of March 2025 -

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

- XYNGARI™ Phase 3 STAR-1 trial enrolled 520 patients with moderate-to-severe acne in the U.S.
and Latin America -

SAN DIEGO, March 4, 2025 /PRNewswire/ -- Dermata Therapeutics, Inc. (Nasdaq: DRMA, 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 the last patient has completed their last visit in the Company's first pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial of XYNGARI™, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. The Company remains on track to announce topline data by the end of March 2025.

"We wish to thank the patients and investigators for their time and commitment to this study. Their efforts helped keep this pivotal Phase 3 trial on schedule. We could not have completed this study without their contribution," commented Christopher Nardo, Ph.D., Dermata's Chief Development Officer. "Throughout the conduct of the study, we have had great interest from our clinical sites, investigators, and study participants as we develop XYNGARI™, which could potentially change how acne is treated. With the last patient visit behind us, we can focus our efforts on cleaning and locking the database, as we plan to report topline data by the end of March," continued Dr. Nardo.  

"This is a great milestone for our team, as we continue to examine the acne market, we believe there is still a high unmet need by patients for an acne product like XYNGARI™," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "Unlike traditional acne therapies, XYNGARI™ is designed as a once-weekly, natural, topical treatment with multiple mechanisms of action that target the root causes of acne. We believe XYNGARI™ acts by reducing inflammation, unclogging pores, and addressing both the inflammatory and noninflammatory lesions, thereby having the potential to provide a more effective, convenient, and well-tolerated alternative to current acne treatments. If approved by FDA, XYNGARI™ could change the standard of care of millions of patients struggling with acne."

XYNGARI™ Phase 3 STAR-1 Clinical Study Design

The XYNGARI™ Phase 3 STAR-1 clinical study will evaluate the efficacy, safety, and tolerability of XYNGARI™ in patients with moderate-to-severe facial acne. The STAR-1 study was 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 were treated once-a-week for 12 weeks with either XYNGARI™ or placebo and were 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 the Phase 3 program would be used to support the filing of a new drug application with the U.S. Food and Drug Administration.

About XYNGARI™ (formerly DMT310)

XYNGARI™ is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. XYNGARI™ 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. XYNGARI™ has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where XYNGARI™ applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. XYNGARI™ 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 U.S. 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, XYNGARI™, is the first product candidate being developed from its Spongilla technology platform. XYNGARI™ is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, XYNGARI™ has been studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its XYNGARI™ product candidate 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 XYNGARI™ development activities and ongoing and planned clinical trials; and whether the results of XYNGARI™ 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/dermata-announces-that-last-patient-completes-last-visit-in-pivotal-xyngari-phase-3-star-1-clinical-trial-for-acne-302390817.html

SOURCE Dermata Therapeutics, Inc.

FAQ

When will Dermata (DRMA) release XYNGARI Phase 3 STAR-1 trial results?

Dermata will announce XYNGARI Phase 3 STAR-1 topline results by the end of March 2025.

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

The STAR-1 trial enrolled 520 patients with moderate-to-severe acne across the United States and Latin America.

What makes DRMA's XYNGARI different from traditional acne treatments?

XYNGARI is a once-weekly, natural, topical treatment with multiple mechanisms of action that reduce inflammation, unclog pores, and target both inflammatory and noninflammatory lesions.

What are the primary endpoints for DRMA's XYNGARI STAR-1 Phase 3 trial?

The primary endpoints include mean change in inflammatory and noninflammatory lesion counts and achieving at least a 2-point improvement in Investigator Global Assessment (IGA) score.