Dermata Therapeutics announced today that the last patient has completed their final visit in the pivotal Phase 3 STAR-1 clinical trial of XYNGARI™, the company's novel once-weekly topical treatment for moderate-to-severe acne. The company remains on track to report topline data by the end of March 2025.
The Phase 3 STAR-1 trial enrolled 520 patients with moderate-to-severe acne across clinical sites in the United States and Latin America. Patients aged 9 years and older were randomized in a 2:1 ratio to receive either XYNGARI or placebo once weekly for 12 weeks.
"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."
Novel Mechanism of Action
XYNGARI represents a significant departure from traditional acne therapies. Derived from a freshwater sponge, the product combines both mechanical and chemical mechanisms of action. The sponge powder contains precisely sized silica spicules that exfoliate the skin, promote collagen production, and create microchannels that facilitate penetration of the sponge's naturally occurring compounds.
These compounds have demonstrated both antimicrobial and anti-inflammatory properties in laboratory studies, potentially addressing multiple aspects of acne pathophysiology simultaneously. The product is designed to be applied just once weekly, in contrast to most current acne treatments that require daily application.
Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer, emphasized the unmet need in the acne market: "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."
Trial Design and Endpoints
The STAR-1 study is evaluating XYNGARI's efficacy, safety, and tolerability in patients with moderate-to-severe facial acne. 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 evaluated monthly throughout the 12-week treatment period.
This study represents the first of two pivotal Phase 3 trials required for regulatory submission. If successful, the results from the Phase 3 program would support a new drug application to the U.S. Food and Drug Administration.
Promising Phase 2b Results
XYNGARI has previously demonstrated efficacy in a Phase 2b study for moderate-to-severe acne. In that trial, XYNGARI applied once weekly achieved statistically significant results at all timepoints for all primary and secondary endpoints. Notably, almost 45% of patients achieved an IGA score of clear or almost clear, compared with less than 18% of placebo patients at the end of the 12-week treatment period.
Addressing a Significant Market Need
Acne vulgaris affects over 30 million patients in the United States who seek treatment annually, with approximately 85% of U.S. teenagers experiencing some form of acne. Many individuals continue to suffer from acne into their 30s, 40s, and beyond.
The condition is characterized by areas of scaly red skin, blackheads, whiteheads, inflammatory papules and pustules, and occasionally cysts and scarring. While not life-threatening, acne can cause significant psychological distress, including social stigma, risk of permanent facial scarring, lowered self-esteem, and social withdrawal.
Current treatment options often require daily application and may cause side effects such as skin dryness, irritation, or systemic effects. A once-weekly natural treatment with multiple mechanisms of action could potentially address many of the limitations of existing therapies.
"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," Dr. Nardo stated. "If approved by FDA, XYNGARI could change the standard of care of millions of patients struggling with acne."
About Dermata Therapeutics
Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions and diseases. In addition to developing XYNGARI for acne, the company has studied the product candidate for psoriasis and rosacea. Dermata is also developing DMT410, which uses XYNGARI as a new method for needle-free intradermal delivery of botulinum toxin for various aesthetic and medical skin conditions.
The company is headquartered in San Diego, California, and trades on the Nasdaq under the symbols DRMA and DRMAW.
