Trial will evaluate once-daily VYN201 gel in subjects with either active or stable nonsegmental vitiligo
Top-line data from the 24-week double-blind portion of the trial expected in mid-2025
The randomized, double-blind, vehicle-controlled trial will evaluate the safety and efficacy of once-daily VYN201 topical gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks. A total of approximately 160 subjects will be randomized at a 1:1:1:1 ratio. Following the 24-week treatment period, subjects in the active treatment arms will continue for an additional 28 weeks, and subjects in the vehicle group will be equally re-randomized to receive VYN201 1%, 2% or 3% gel for an additional 28 weeks. The primary efficacy endpoint of the trial is the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least 50% from baseline (F-VASI50) at week 24 compared to vehicle, with additional secondary endpoints of F-VASI and Total VASI (T-VASI) at weeks 24 and 52.
“Dosing the first subject in the Phase 2b trial for vitiligo is an important milestone for the VYN201 program and our Company,” said
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 0.5-2.0% of the world population. There is currently only one FDA-approved product for the treatment of vitiligo. Nonsegmental vitiligo is the most common type of vitiligo.
About VYN201
VYN201 is a pan-bromodomain
About BET Inhibitors
About
VYNE’s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company’s unique and proprietary bromodomain & extra-terminal (BET) domain inhibitors, which comprise its InhiBET™ platform, include a locally administered pan-BD BET inhibitor (VYN201) and an orally available BD2-selective
For more information about
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 the potential benefits of VYN201 as a therapy for nonsegmental vitiligo and the expected timing for receipt of top-line results from the Phase 2b trial in mid-2025. 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 enroll subjects in its clinical trials and 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
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