Dermata Announces that Last Patient Completes Last Visit in Pivotal XYNGARI™ Phase 3 STAR-1 Clinical Trial for Acne
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.
Dermata Therapeutics (NASDAQ: DRMA) ha annunciato il completamento dell'ultima visita del paziente nel loro studio clinico cruciale di Fase 3 STAR-1 per XYNGARI™, un nuovo trattamento topico settimanale per l'acne da moderata a grave. Lo studio ha arruolato 520 pazienti negli Stati Uniti e in America Latina, con risultati preliminari attesi entro la fine di marzo 2025.
Lo studio STAR-1 è uno studio randomizzato (2:1), in doppio cieco e controllato con placebo che valuta l'efficacia, la sicurezza e la tollerabilità di XYNGARI. Gli obiettivi primari includono le variazioni nel numero di lesioni infiammatorie e non infiammatorie e la risposta al trattamento secondo la valutazione globale dell'investigatore (IGA). Il periodo di trattamento è durato 12 settimane, con valutazioni mensili.
XYNGARI™ mira a colpire diversi meccanismi dell'acne, inclusa la riduzione dell'infiammazione e la disostruzione dei pori. Con oltre 30 milioni di pazienti affetti da acne che cercano trattamento annualmente negli Stati Uniti, questo rappresenta il primo di due studi cruciali di Fase 3 necessari per la presentazione della domanda di nuovo farmaco alla FDA.
Dermata Therapeutics (NASDAQ: DRMA) ha anunciado la finalización de la última visita del paciente en su ensayo clínico pivotal de Fase 3 STAR-1 para XYNGARI™, un novedoso tratamiento tópico semanal para el acné moderado a severo. El ensayo incluyó a 520 pacientes en EE. UU. y América Latina, con resultados preliminares esperados para finales de marzo de 2025.
El estudio STAR-1 es un ensayo aleatorizado (2:1), doble ciego y controlado con placebo que evalúa la eficacia, seguridad y tolerabilidad de XYNGARI. Los objetivos primarios incluyen cambios en el conteo de lesiones inflamatorias y no inflamatorias y la respuesta al tratamiento según la Evaluación Global del Investigador (IGA). El período de tratamiento duró 12 semanas, con evaluaciones mensuales.
XYNGARI™ aborda múltiples mecanismos del acné, incluida la reducción de la inflamación y la desobstrucción de los poros. Con más de 30 millones de pacientes con acné que buscan tratamiento anualmente en EE. UU., este representa el primero de dos estudios pivotal de Fase 3 necesarios para la presentación de una nueva solicitud de medicamento a la FDA.
Dermata Therapeutics (NASDAQ: DRMA)는 중증에서 중등도의 여드름에 대한 새로운 주 1회 국소 치료제인 XYNGARI™의 주요 3상 STAR-1 임상 시험에서 마지막 환자 방문이 완료되었음을 발표했습니다. 이 시험은 미국과 라틴 아메리카에서 520명의 환자를 등록했으며, 주요 결과는 2025년 3월 말까지 예상됩니다.
STAR-1 연구는 XYNGARI의 효능, 안전성 및 내약성을 평가하는 무작위(2:1), 이중 맹검, 위약 대조 시험입니다. 주요 목표에는 염증성 및 비염증성 병변 수의 변화와 연구자의 전반적인 평가(IGA) 치료 반응이 포함됩니다. 치료 기간은 12주였으며, 매월 평가가 이루어졌습니다.
XYNGARI™는 염증 감소와 모공 막힘 해소를 포함한 여러 여드름 메커니즘을 타겟으로 합니다. 미국에서 매년 3천만 명 이상의 여드름 환자가 치료를 찾고 있는 만큼, 이는 FDA 신약 신청 제출을 위해 필요한 두 개의 주요 3상 연구 중 첫 번째를 나타냅니다.
Dermata Therapeutics (NASDAQ: DRMA) a annoncé l'achèvement de la dernière visite du patient dans leur essai clinique pivot de Phase 3 STAR-1 pour XYNGARI™, un nouveau traitement topique hebdomadaire pour l'acné modérée à sévère. L'essai a recruté 520 patients aux États-Unis et en Amérique latine, avec des résultats préliminaires attendus d'ici la fin mars 2025.
L'étude STAR-1 est un essai randomisé (2:1), en double aveugle et contrôlé par placebo évaluant l'efficacité, la sécurité et la tolérabilité de XYNGARI. Les objectifs principaux incluent les changements dans le nombre de lésions inflammatoires et non inflammatoires ainsi que la réponse au traitement selon l'évaluation globale de l'investigateur (IGA). La période de traitement a duré 12 semaines, avec des évaluations mensuelles.
XYNGARI™ cible plusieurs mécanismes de l'acné, y compris la réduction de l'inflammation et le désobstruction des pores. Avec plus de 30 millions de patients souffrant d'acné cherchant un traitement chaque année aux États-Unis, cela représente le premier de deux études pivot de Phase 3 nécessaires pour la soumission d'une nouvelle demande de médicament à la FDA.
Dermata Therapeutics (NASDAQ: DRMA) hat den Abschluss des letzten Patientenbesuchs in ihrer entscheidenden Phase-3-Studie STAR-1 für XYNGARI™ bekannt gegeben, eine neuartige topische Behandlung für mittelschwere bis schwere Akne, die einmal wöchentlich angewendet wird. Die Studie umfasste 520 Patienten in den USA und Lateinamerika, wobei die vorläufigen Ergebnisse bis Ende März 2025 erwartet werden.
Die STAR-1-Studie ist eine randomisierte (2:1), doppelblinde, placebo-kontrollierte Studie, die die Wirksamkeit, Sicherheit und Verträglichkeit von XYNGARI bewertet. Zu den primären Endpunkten gehören Veränderungen der Anzahl entzündlicher und nicht-entzündlicher Läsionen sowie die Behandlungseffizienz gemäß der Globalen Bewertung durch den Prüfer (IGA). Die Behandlungsdauer betrug 12 Wochen, mit monatlichen Bewertungen.
XYNGARI™ zielt auf mehrere Akne-Mechanismen ab, einschließlich der Reduzierung von Entzündungen und der Öffnung verstopfter Poren. Mit über 30 Millionen Aknepatienten, die jährlich in den USA eine Behandlung suchen, stellt dies die erste von zwei entscheidenden Phase-3-Studien dar, die für die Einreichung eines neuen Arzneimittelantrags bei der FDA erforderlich sind.
- 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
- 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
Insights
Dermata's announcement marks a significant milestone in their clinical development program for XYNGARI™, a novel once-weekly topical acne treatment. Completing the last patient visit in this pivotal Phase 3 trial keeps the company on track to report topline data this month, representing a critical near-term catalyst for this micro-cap biotech (
The STAR-1 trial's design is robust - a randomized, double-blind, placebo-controlled study with 520 patients across multiple countries. The primary endpoints measuring both lesion count reduction and Investigator Global Assessment are standard for acne trials and align with FDA requirements. With once-weekly application versus daily treatments required by most competitors, XYNGARI™ targets a substantial market opportunity with 30 million U.S. acne patients annually seeking treatment.
What's particularly notable is this product's differentiated approach with multiple mechanisms targeting inflammation, pore clogging, and both inflammatory and non-inflammatory lesions. However, despite management's optimism, the trial completion merely sets the stage for the all-important efficacy results. Without data on safety and efficacy, this milestone represents execution progress but doesn't yet validate the product's potential. This is the first of two required pivotal trials needed for FDA submission, putting any potential approval still well in the future.
The completion of patient visits in this pivotal Phase 3 acne trial represents clean operational execution by Dermata's clinical team. Trial completion on schedule is noteworthy in the current clinical research environment, where delays are common. The 2:1 randomization ratio (treatment:placebo) is standard for dermatology trials, balancing statistical power with ethical considerations of minimizing placebo exposure.
The trial's dual primary endpoints reflect regulatory requirements: quantitative lesion count reduction combined with the more subjective Investigator Global Assessment (IGA) requiring a 2-point improvement and achievement of "clear" or "almost clear" skin. This rigorous success threshold ensures clinical meaningfulness if met.
From a development perspective, once-weekly administration represents a potential adherence advantage, as patient compliance with daily topical regimens is a well-documented challenge in dermatology. The trial's inclusion of patients as young as 9 years old is also strategically important for potential label breadth.
While the completion of the last patient visit is procedurally significant, investors should understand that database lock, cleaning, and analysis typically take several weeks. The company's projection of results this month suggests confidence in their data management processes. However, without efficacy signals, this milestone primarily represents execution against timeline rather than validation of the product candidate itself.
- STAR-1 topline results expected by the end of March 2025 -
- Over 30 million acne patients seek treatment in the
- XYNGARI™ Phase 3 STAR-1 trial enrolled 520 patients with moderate-to-severe acne in the
and
"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
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
About Acne Vulgaris
Over 30 million acne patients in the
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
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
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SOURCE Dermata Therapeutics, Inc.
FAQ
When will Dermata (DRMA) release XYNGARI Phase 3 STAR-1 trial results?
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