VYNE Therapeutics Inc. has completed 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.
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.
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 (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks in subjects with active or stable nonsegmental vitiligo. Subjects have been randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle (~45 subjects in each arm). Following the 24-week treatment period, subjects who have been randomized in the 1%, 2% and 3% cohorts will have the option to continue treatment with their respective dose concentrations for an additional 28-week extension. Subjects who have been randomized in the vehicle group during the initial 24-week treatment period will be equally re-randomized into one of the three active dose cohorts 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 including F-VASI and Total VASI (T-VASI) at weeks 24 and 52.
