VYNE Therapeutics Completes Enrollment in Phase 2b Trial Evaluating VYN201 for the Treatment of Nonsegmental Vitiligo
VYNE Therapeutics has completed enrollment in its Phase 2b trial evaluating VYN201 gel (repibresib) for the treatment of nonsegmental vitiligo. The company expects to report top-line data from the 24-week vehicle-controlled treatment period in mid-2025.
The trial represents a significant milestone in the development of VYN201, which VYNE believes has the potential to become a differentiated therapy for vitiligo patients. The United States Adopted Names (USAN) Council has officially adopted "repibresib" as the non-proprietary name for the new chemical entity in VYN201.
VYNE Therapeutics ha completato l'arruolamento nella sua sperimentazione clinica di Fase 2b che valuta VYN201 gel (repibresib) per il trattamento del vitiligine non segmentale. L'azienda prevede di riportare i dati principali relativi al periodo di trattamento controllato con veicolo di 24 settimane entro la metà del 2025.
Lo studio rappresenta una significativa tappa nello sviluppo di VYN201, che VYNE crede abbia il potenziale per diventare una terapia differenziata per i pazienti con vitiligine. Il Consiglio dei Nominalisti Statunitensi (USAN) ha ufficialmente adottato "repibresib" come nome non proprietario per la nuova entità chimica di VYN201.
VYNE Therapeutics ha completado la inscripción en su ensayo clínico de Fase 2b que evalúa VYN201 gel (repibresib) para el tratamiento del vitíligo no segmentario. La compañía espera informar sobre los datos iniciales del periodo de tratamiento controlado con vehículo de 24 semanas a mediados de 2025.
El ensayo representa un hito significativo en el desarrollo de VYN201, que VYNE cree que tiene el potencial de convertirse en una terapia diferenciada para los pacientes con vitíligo. El Consejo de Nombres Adoptados de los Estados Unidos (USAN) ha adoptado oficialmente "repibresib" como el nombre no propietario de la nueva entidad química en VYN201.
VYNE Therapeutics는 비분절 백반증 치료를 위해 VYN201 젤 (repibresib)의 평가를 위한 2b상 임상시험의 등록을 완료했습니다. 이 회사는 2025년 중반에 24주 차량 대조 치료 기간의 주요 데이터를 보고할 계획입니다.
이번 시험은 VYN201 개발의 중요한 이정표를 나타내며, VYNE은 이 치료제가 백반증 환자에게 차별화된 치료제가 될 잠재력이 있다고 믿고 있습니다. 미국 비독점 이름 위원회(USAN)는 VYN201의 새로운 화학 물질에 대해 "repibresib"라는 비독점 이름을 공식적으로 채택했습니다.
VYNE Therapeutics a terminé le recrutement dans son essai de Phase 2b évaluant le gel VYN201 (repibresib) pour le traitement du vitiligo non segmentaire. La société s'attend à communiquer les données principales concernant la période de traitement contrôlée par un véhicule de 24 semaines à la mi-2025.
L'essai représente une étape significative dans le développement de VYN201, que VYNE croit avoir le potentiel de devenir une thérapie différenciée pour les patients atteints de vitiligo. Le Conseil des Noms Adoptés des États-Unis (USAN) a officiellement adopté "repibresib" comme nom non propriétaire pour la nouvelle entité chimique contenue dans VYN201.
VYNE Therapeutics hat die Rekrutierung in seiner Phase-2b-Studie abgeschlossen, die VYN201 Gel (repibresib) zur Behandlung von nicht segmentalem Vitiligo evaluiert. Das Unternehmen plant, mitte 2025 die wichtigsten Daten aus der 24-wöchigen Plazebokontrollphase zu berichten.
Die Studie stellt einen bedeutenden Meilenstein in der Entwicklung von VYN201 dar, von dem VYNE glaubt, dass es das Potenzial hat, eine differenzierte Therapie für Vitiligo-Patienten zu werden. Der United States Adopted Names (USAN) Council hat
- Successfully completed enrollment in Phase 2b trial
- Clear timeline established for top-line data release in mid-2025
- Obtained USAN approval for non-proprietary name 'repibresib'
- None.
Insights
The completion of enrollment in VYNE's Phase 2b trial for VYN201 (repibresib) represents a important development milestone. The trial's design as a vehicle-controlled, double-blind study evaluating a once-daily gel formulation for nonsegmental vitiligo positions it as a potentially significant advancement in dermatology therapeutics. Nonsegmental vitiligo affects approximately 2% of the global population, with effective topical treatment options currently available.
The timing of top-line data readout in mid-2025 aligns with typical Phase 2b trial durations, incorporating a 24-week treatment period that should provide robust efficacy and safety data. For context, this timeline is particularly important as it could position VYNE to potentially enter Phase 3 trials by early 2026 if the data proves positive. The USAN approval of the non-proprietary name "repibresib" also indicates progression toward potential commercialization, though several development hurdles remain.
For investors, it's important to understand that while trial enrollment completion reduces operational risk, the most significant binary event remains the mid-2025 data readout. With VYNE's relatively small market cap of
The vitiligo treatment market represents a substantial commercial opportunity, currently valued at approximately
The completion of enrollment signals strong investigator and patient interest, critical factors for potential commercial success. Competing therapies in development or recently approved primarily consist of systemic treatments or combination approaches, potentially giving VYN201's topical-only approach a distinct market advantage if efficacy is demonstrated. The once-daily application format aligns with patient preference for convenient treatment regimens, which could drive better adherence and market adoption.
From an investment perspective, VYNE's focus on inflammatory and immune-mediated conditions positions it in a high-growth therapeutic area. The company's current market capitalization suggests significant upside potential if Phase 2b results prove positive, though investors should note that clinical-stage biotech investments carry substantial risks, particularly for companies with pipeline diversity.
- Once-daily VYN201 gel being evaluated in subjects with nonsegmental vitiligo
- Top-line data from the 24-week double-blind portion of the trial expected in mid-2025
- “Repibresib” approved as the non-proprietary name for VYN201 by USAN
BRIDGEWATER, N.J., Jan. 06, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced completion of enrollment in the Phase 2b trial evaluating VYN201 gel for the treatment of nonsegmental vitiligo. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025.
“We are pleased to have recently completed enrollment in our Phase 2b trial evaluating VYN201 for the treatment of vitiligo, which marks an important milestone for the program and reflects the continued strong execution of our clinical team,” said David Domzalski, President and Chief Executive Officer of VYNE. “We believe VYN201 gel has the potential to become a differentiated therapy for patients with vitiligo, and we look forward to reporting top-line data from this Phase 2b trial in the middle of this year.”
Additionally, the United States Adopted Names (USAN) Council has adopted “repibresib” as the non-proprietary name for the new chemical entity in VYN201. VYNE will use the name repibresib in public statements, at conferences and other forums, and in corporate-related materials as the Company continues to advance the clinical development of the product.
About the Phase 2b Trial for Repibresib Gel (NCT06493578)
The Phase 2b trial is a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily repibresib gel in three dose cohorts (
The primary efficacy endpoint of the trial is the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least
About Vitiligo
Vitiligo is a chronic autoimmune depigmenting disorder of the skin, characterized by the loss of pigment producing cells known as melanocytes. Vitiligo is the most common depigmenting skin condition, with a prevalence estimated at 0.5
About Repibresib
Repibresib is a pan-bromodomain BET inhibitor designed to be locally administered as a “soft” drug to address diseases involving multiple, diverse inflammatory cell signaling pathways, while providing low systemic exposure. In addition to demonstrating clinical proof-of-concept in vitiligo, repibresib has produced consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity in several preclinical models (using several different routes of administration).
About BET Inhibitors
BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”). Recent research has identified a key role for these proteins in regulating activation of immune cells, including T cells and B cells, and subsequent inflammatory and fibrotic processes. As epigenetic readers, BET proteins regulate the recruitment of transcriptional factors that are key to the production of several pro-inflammatory cytokines. BET inhibitors have the potential to treat a range of immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription, with additional potential in myeloproliferative neoplastic disorders.
About VYNE Therapeutics Inc.
VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE’s unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity.
For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission (“SEC”), public conference calls, and webcasts.
Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to VYNE’s ability to successfully complete the Phase 2b trial evaluating repibresib gel for the treatment of nonsegmental vitiligo, as well as the timing of results in mid-2025, and the potential benefits of repibresib. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to enroll patients in its clinical trials and successfully develop its product candidates; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2023 and VYNE’s other filings from time to time with the SEC. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.
Investor Relations:
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Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
Tyler.Zeronda@vynetx.com
Media Relations:
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FAQ
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