Dermata Completes Enrollment in First Pivotal DMT310 Phase 3 STAR-1 Clinical Trial for Acne
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.
Dermata Therapeutics (NASDAQ:DRMA) ha completato l'arruolamento nel suo studio clinico pivotale di Fase 3 STAR-1 per DMT310, un trattamento topico settimanale per l'acne da moderata a grave. Lo studio ha arruolato 520 pazienti di età pari o superiore a 9 anni negli Stati Uniti e in America Latina, con risultati preliminari attesi per marzo 2025. Questo studio randomizzato, in doppio cieco e controllato con placebo è il primo di due studi di Fase 3 necessari per supportare la presentazione di una NDA. La sperimentazione valuterà l'efficacia attraverso il conteggio delle lesioni infiammatorie e non infiammatorie e i punteggi della Valutazione Globale da parte dell'Investigatore durante un periodo di trattamento di 12 settimane.
Dermata Therapeutics (NASDAQ:DRMA) ha completado la inscripción en su ensayo clínico pivotal de Fase 3 STAR-1 para DMT310, un tratamiento tópico semanal para el acné de moderado a grave. El estudio incluyó a 520 pacientes de 9 años en adelante en EE. UU. y América Latina, y se esperan resultados preliminares en marzo de 2025. Este estudio aleatorizado, doble ciego y controlado con placebo es el primero de dos ensayos de Fase 3 necesarios para apoyar la presentación de una NDA. El ensayo evaluará la eficacia a través del conteo de lesiones inflamatorias y no inflamatorias, así como las puntuaciones de Evaluación Global del Investigador durante un período de tratamiento de 12 semanas.
Dermata Therapeutics (NASDAQ:DRMA)는 중등도에서 중증 여드름 치료를 위한 주 1회 국소 치료제인 DMT310의 주요 3상 임상 시험 STAR-1의 등록을 완료했습니다. 이 연구에는 9세 이상 환자 520명이 미국과 라틴 아메리카에서 등록되었으며, 주요 결과는 2025년 3월에 예상됩니다. 이 무작위, 이중 맹검, 위약 대조 연구는 NDA 제출을 지원하기 위해 필요한 두 개의 3상 시험 중 첫 번째입니다. 이 시험은 12주 치료 기간 동안 염증성 및 비염증성 병변 수와 연구자 글로벌 평가 점수를 통해 효능을 평가합니다.
Dermata Therapeutics (NASDAQ:DRMA) a achevé le recrutement dans son essai clinique pivot de Phase 3 STAR-1 pour DMT310, un traitement topique hebdomadaire pour l'acné modérée à sévère. L'étude a recruté 520 patients âgés de 9 ans et plus aux États-Unis et en Amérique latine, avec des résultats préliminaires attendus en mars 2025. Cette étude randomisée, en double aveugle et contrôlée par placebo est la première de deux essais de Phase 3 nécessaires pour soutenir une demande NDA. L'essai évaluera l'efficacité par le biais du comptage des lésions inflammatoires et non inflammatoires ainsi que des scores d'évaluation globale de l'investigateur sur une période de traitement de 12 semaines.
Dermata Therapeutics (NASDAQ:DRMA) hat die Rekrutierung in seiner wegweisenden Phase-3-Studie STAR-1 für DMT310 abgeschlossen, eine wöchentliche topische Behandlung für mäßige bis schwere Akne. Die Studie hat 520 Patienten im Alter von 9 Jahren und älter in den USA und Lateinamerika eingeschlossen, wobei mit ersten Ergebnissen im März 2025 gerechnet wird. Diese randomisierte, doppelblinde, placebo-kontrollierte Studie ist die erste von zwei Phase-3-Studien, die zur Unterstützung eines NDA-Antrags erforderlich sind. Die Studie wird die Wirksamkeit durch die Zählung von entzündlichen und nichtentzündlichen Läsionen sowie die Bewertungen der globalen Untersuchung durch den Prüfer über einen Behandlungszeitraum von 12 Wochen bewerten.
- 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
- 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
Insights
The completion of enrollment in DMT310's first Phase 3 trial represents a significant milestone for Dermata's acne treatment program. The study design is robust with 520 patients and a 2:1 randomization ratio, providing strong statistical power. Previous Phase 2b success across all primary endpoints increases confidence in potential Phase 3 outcomes.
The once-weekly application format could be a major differentiator in the crowded acne market, addressing key patient pain points around compliance and tolerability. The 30 million patient addressable market in the U.S. presents substantial commercial opportunity if approved. With topline results expected in March 2025 and a second Phase 3 trial planned, positive outcomes could lead to an NDA filing, potentially transforming Dermata from a clinical-stage to commercial-stage company.
- 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
About Acne Vulgaris
Over 30 million acne patients in the U.S. seek treatment each year, with about
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?
How many patients were enrolled in DRMA's Phase 3 STAR-1 acne trial?
What are the primary endpoints for Dermata's (DRMA) DMT310 Phase 3 trial?
How frequently is DMT310 administered in DRMA's Phase 3 trial?
