VYNE Therapeutics Provides Update on VYN202 Program
VYNE Therapeutics (Nasdaq: VYNE) announced that the FDA has placed a clinical hold on its Phase 1b study of VYN202 for moderate-to-severe plaque psoriasis treatment. The hold follows the discovery of testicular toxicity in dogs during non-clinical toxicology studies.
The company has suspended all screening, enrollment, and patient dosing for the VYN202 trial. While no serious adverse events have been reported in enrolled subjects, VYNE will work with the FDA to resolve the clinical hold.
Importantly, the clinical hold does not affect VYNE's ongoing Phase 2b trial of repibresib gel in nonsegmental vitiligo, which is a distinct compound from VYN202. Top-line results from the 24-week double-blind, vehicle-controlled portion of this trial are expected mid-year.
VYNE Therapeutics (Nasdaq: VYNE) ha annunciato che la FDA ha imposto un blocco clinico sullo studio di Fase 1b di VYN202 per il trattamento della psoriasi a placche da moderata a grave. Il blocco è stato deciso a seguito della scoperta di tossicità testicolare nei cani durante studi tossicologici non clinici.
L'azienda ha sospeso tutte le attività di screening, arruolamento e somministrazione ai pazienti per lo studio su VYN202. Sebbene non siano stati segnalati eventi avversi gravi nei soggetti arruolati, VYNE collaborerà con la FDA per risolvere il blocco clinico.
È importante sottolineare che il blocco clinico non riguarda lo studio di Fase 2b in corso di repibresib gel per il vitiligine non segmentale, che è un composto distinto da VYN202. I risultati principali della parte a doppio cieco controllata con veicolo di 24 settimane di questo studio sono attesi a metà anno.
VYNE Therapeutics (Nasdaq: VYNE) anunció que la FDA ha impuesto una suspensión clínica en su estudio de Fase 1b de VYN202 para el tratamiento de la psoriasis en placas de moderada a grave. La suspensión se debe al hallazgo de toxicidad testicular en perros durante estudios toxicológicos no clínicos.
La compañía ha detenido todas las actividades de selección, inscripción y dosificación de pacientes para el ensayo de VYN202. Aunque no se han reportado eventos adversos graves en los sujetos inscritos, VYNE trabajará con la FDA para levantar la suspensión clínica.
Es importante destacar que la suspensión clínica no afecta el ensayo en curso de Fase 2b de gel de repibresib para vitíligo no segmentario, que es un compuesto diferente a VYN202. Se esperan los resultados principales de la parte doble ciego controlada con vehículo de 24 semanas a mediados de año.
VYNE Therapeutics (나스닥: VYNE)는 FDA가 중등도에서 중증 판상 건선 치료를 위한 VYN202의 1b상 임상시험에 대해 임상 중단 조치를 내렸다고 발표했습니다. 이 중단은 비임상 독성 연구 중 개에서 고환 독성이 발견된 데 따른 것입니다.
회사는 VYN202 임상시험의 모든 선별, 등록 및 환자 투약을 중단했습니다. 등록된 피험자에게서 심각한 이상 반응은 보고되지 않았지만, VYNE는 FDA와 협력하여 임상 중단 문제를 해결할 예정입니다.
중요한 점은 이번 임상 중단이 VYN202와는 별개의 화합물인 비분절성 백반증 치료용 레피브레시브 겔의 진행 중인 2b상 시험에는 영향을 미치지 않는다는 것입니다. 이 시험의 24주간 이중맹검, 차량 대조 구간의 주요 결과는 연중 중반에 발표될 예정입니다.
VYNE Therapeutics (Nasdaq : VYNE) a annoncé que la FDA a imposé une mise en attente clinique de son étude de Phase 1b sur VYN202 pour le traitement du psoriasis en plaques modéré à sévère. Cette mise en attente fait suite à la découverte d’une toxicité testiculaire chez des chiens lors d’études toxicologiques non cliniques.
La société a suspendu toutes les phases de sélection, d’inclusion et d’administration aux patients pour l’essai VYN202. Aucun événement indésirable grave n’ayant été signalé chez les sujets inclus, VYNE collaborera avec la FDA pour lever cette mise en attente clinique.
Il est important de noter que cette mise en attente clinique n’affecte pas l’essai de Phase 2b en cours sur le gel de repibresib dans le vitiligo non segmentaire, qui est un composé distinct de VYN202. Les résultats principaux de la phase en double aveugle contrôlée par véhicule de 24 semaines de cet essai sont attendus à la mi-année.
VYNE Therapeutics (Nasdaq: VYNE) gab bekannt, dass die FDA einen klinischen Stopp für die Phase-1b-Studie von VYN202 zur Behandlung von mittelschwerer bis schwerer Plaque-Psoriasis verhängt hat. Der Stopp folgt auf die Entdeckung von Hoden-Toxizität bei Hunden während nichtklinischer Toxikologiestudien.
Das Unternehmen hat alle Screenings, Einschreibungen und Patientendosierungen für die VYN202-Studie ausgesetzt. Obwohl bei den eingeschlossenen Probanden keine schwerwiegenden unerwünschten Ereignisse gemeldet wurden, wird VYNE mit der FDA zusammenarbeiten, um den klinischen Stopp aufzuheben.
Wichtig ist, dass der klinische Stopp die laufende Phase-2b-Studie mit Repibresib-Gel bei nichtsegmentalem Vitiligo nicht betrifft, da es sich um eine andere Substanz als VYN202 handelt. Die Hauptergebnisse des 24-wöchigen doppelblinden, fahrzeugkontrollierten Abschnitts dieser Studie werden Mitte des Jahres erwartet.
- No serious adverse events reported in VYN202 Phase 1b trial participants
- Phase 2b trial of repibresib gel continues unaffected
- Top-line results for repibresib gel trial expected mid-year
- FDA clinical hold placed on VYN202 Phase 1b psoriasis trial
- Testicular toxicity discovered in dogs during VYN202 toxicology studies
- Complete suspension of screening, enrollment, and dosing in VYN202 trial
BRIDGEWATER, N.J., April 25, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company that it placed a clinical hold on the Company’s Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis. The clinical hold determination was made following a recent observation of testicular toxicity in dogs from a non-clinical toxicology study with VYN202.
VYNE has suspended all screening, enrollment and patient dosing in the Phase 1b trial of VYN202 and intends to work diligently with the FDA to resolve the clinical hold as soon as possible. To date, there have been no serious adverse events observed in subjects that have been enrolled in the Phase 1b study.
The clinical hold does not apply to VYNE’s ongoing Phase 2b trial of repibresib gel in nonsegmental vitiligo. Repibresib is a distinct and unique compound from VYN202. Top-line results from the 24-week double-blind, vehicle-controlled portion of the Phase 2b trial are expected mid-year.
“While we are disappointed by this unexpected development, the safety and well-being of patients in our studies is our top priority,” said David Domzalski, President and Chief Executive Officer of VYNE. “We intend to work closely with the FDA to address the clinical hold as expeditiously as possible and we plan to provide additional updates pending continued engagement with FDA.”
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, public conference calls, and webcasts.
Investor Relations:
John Fraunces
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Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
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Media Relations:
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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 regarding the clinical development of, and timing for reporting top-line results from trials of, repibresib and VYN202, the resolution of the clinical hold, and other statements regarding the future expectations, plans and prospects of VYNE. 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 successfully develop its product candidates; the timing of commencement of future preclinical studies and clinical trials; 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, 2024, and VYNE’s other filings from time to time with the U.S. Securities and Exchange Commission. 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.
FAQ
What caused the FDA clinical hold on VYNE Therapeutics' VYN202 trial?
Does the clinical hold affect VYNE's Phase 2b repibresib gel trial for vitiligo?
When will VYNE Therapeutics release results for its Phase 2b repibresib gel trial?
Have there been any serious adverse events in the VYN202 Phase 1b trial?
