VYNE Therapeutics Inc. 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. 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 vitiligigo. 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. Vitiligo is a chronic autoimmune depigmenting disorder of the skin, characterized by the loss of pigment producing cells known as melanocytes.itiligo 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. 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. 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.