Core Insights - VYNE Therapeutics announced that its Phase 2b trial for Repibresib gel in nonsegmental vitiligo did not meet its primary endpoint of achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to the vehicle group [1][2][4] - Despite missing the primary and key secondary endpoints, nominally statistically significant effects were observed in some exploratory endpoints, indicating potential efficacy at the highest dose [2][4] - The company plans to terminate the ongoing extension phase of the trial and seek an external partner for the continued development of Repibresib [1][4] Trial Details - The Phase 2b trial involved 177 subjects and was a randomized, double-blind, vehicle-controlled study assessing the safety and efficacy of Repibresib at concentrations of 1%, 2%, and 3% [3] - The trial was conducted across 45 sites in North America and evaluated multiple efficacy endpoints, including the primary endpoint of F-VASI50 and key secondary endpoints [3] Efficacy Results - The trial did not meet the primary endpoint, with only 19.5% of subjects in the 3% Repibresib group achieving F-VASI50 compared to 23.4% in the vehicle group [5] - For the key secondary endpoint of F-VASI75, 9.8% of subjects in the 3% group achieved this compared to 6.4% in the vehicle group [6] - The percent change from baseline in F-VASI score at week 24 showed a mean reduction of -43.6% for the 3% Repibresib group versus -25.6% for the vehicle group, indicating a statistically significant treatment effect [7] - The percent change from baseline in T-VASI score at week 24 also showed a significant reduction of -28.3% for the 3% Repibresib group compared to -16.2% for the vehicle group [8] Safety and Tolerability - The trial reported a higher rate of treatment-emergent adverse events (TEAEs) in subjects receiving Repibresib compared to the vehicle group, with application site pain being the most common adverse event [9] - Eight subjects discontinued due to adverse events in the Repibresib group, while none in the vehicle group experienced this [9] Financial Position - As of June 30, 2025, VYNE expects to report approximately $39.6 million in cash, cash equivalents, and investments [4]

Core Viewpoint - VYNE Therapeutics Inc. is advancing its VYN202 program for treating moderate-to-severe plaque psoriasis after the FDA lifted a clinical hold for female patients on lower doses, while further data is needed for male subjects [1][2][4] VYN202 Program Update - The FDA placed a clinical hold on the Phase 1b trial due to testicular toxicity observed in dogs, but has now lifted the hold for female patients on 0.25 mg and 0.5 mg doses [2] - The 1 mg dose was excluded from the revised protocol due to a lower safety margin [2] - A 12-week non-clinical toxicology study is required to resume trials in male subjects, with the study design agreed upon with the FDA [2] Clinical Data Insights - The clinical data from the Phase 1b trial included 7 enrolled subjects, with 6 treated with VYN202 and 1 with placebo [3][5] - No serious adverse events or treatment discontinuations were reported, and all subjects treated with VYN202 showed improvement in psoriasis symptoms [7] - PASI scores improved by approximately 27% after 1 week and up to 90% by week 8 [7] - Significant reductions in serum cytokine levels were observed in subjects treated with VYN202, while no changes were noted in the placebo group [7] Future Plans and Financial Outlook - The company will not enroll new patients in the Phase 1b psoriasis study, extending its expected cash runway into Q4 2026 [4] - Further updates on the VYN202 program will follow the release of top-line results from the ongoing Phase 2b study of repibresib gel for non-segmental vitiligo [4] About VYN202 - VYN202 is an oral small molecule BET inhibitor with potential class-leading selectivity and potency for BD2, aimed at providing a non-biologic treatment option for immuno-inflammatory conditions [10] About VYNE Therapeutics Inc. - VYNE is focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions, leveraging its proprietary BET inhibitors to overcome limitations of earlier generations [11]