VYNE Therapeutics Completes Enrollment in Phase 2b Trial Evaluating VYN201 for the Treatment of Nonsegmental Vitiligo

Core Insights - VYNE Therapeutics Inc. has completed enrollment in its Phase 2b trial for VYN201 gel, aimed at treating nonsegmental vitiligo, with top-line data expected in mid-2025 [1][2][8] Company Overview - VYNE Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions with high unmet needs [9] - The company utilizes a proprietary InhiBET™ platform, which includes unique BET inhibitors designed to enhance selectivity and overcome limitations of earlier generation BET inhibitors [9] Product Development - The Phase 2b trial for VYN201 gel (now named repibresib) is a randomized, double-blind, vehicle-controlled study assessing the efficacy, safety, and pharmacokinetics of the gel in three dose cohorts (1%, 2%, and 3%) over a 24-week period [3][4] - The primary efficacy endpoint is the proportion of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to the vehicle group [4] Disease Context - Vitiligo is a chronic autoimmune disorder characterized by the loss of melanocytes, affecting approximately 0.5-2.0% of the global population, with nonsegmental vitiligo being the most common type [5] - Currently, there is only one FDA-approved treatment for vitiligo, highlighting the significant unmet medical need in this area [5] Mechanism of Action - Repibresib is a pan-bromodomain BET inhibitor designed for local administration, targeting multiple inflammatory cell signaling pathways while minimizing systemic exposure [6] - BET proteins play a crucial role in regulating gene transcription and immune cell activation, making BET inhibitors promising for treating various immuno-inflammatory and fibrotic diseases [7]