VYNE Therapeutics Reports Disappointing Phase 2b Results for Repibresib Gel in Vitiligo Trial, Shares Drop 73%

VYNE Therapeutics Inc. (Nasdaq: VYNE) announced topline results from its Phase 2b trial evaluating Repibresib gel for the treatment of nonsegmental vitiligo, a chronic skin condition where the skin loses its pigment, resulting in white patches. The trial did not meet its primary or key secondary efficacy endpoints, prompting the company to terminate the extension phase of the study and begin seeking a development partner for the drug.

Trial Misses Primary and Key Secondary Endpoints

The study, which enrolled 177 patients across 45 sites in North America, was designed to assess the efficacy and safety of Repibresib gel at three concentrations (1%, 2%, and 3%) applied once daily. The trials primary endpoint was the proportion of patients achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at Week 24 compared to vehicle. None of the treatment arms outperformed vehicle significantly on this measure.

A similar outcome was seen in the key secondary endpoint (F-VASI75), with all active arms showing low response rates and no statistical significance compared to vehicle.

Exploratory Signals at Higher Dose

Despite missing primary endpoints, the 3% Repibresib group showed nominally statistically significant improvements in certain exploratory endpoints.

VYNE attributed the muted trial results in part to an unexpectedly high placebo (vehicle) response and elevated dropout rates in the treatment arms, particularly in the 3% cohort (36.6% dropout vs. 10.6% for vehicle).

Safety and Tolerability

Repibresib was generally well tolerated, although higher rates of treatment-emergent adverse events (TEAEs) were observed compared to vehicle. The most common side effect was application site pain, reported in 14% of subjects using the 3% dose compared to 3.8% for vehicle. Most adverse events were mild and resolved during the study, and there were no dose-dependent increases in skin-related side effects.

One serious adverse event (cholelithiasis) was reported in the 1% cohort but was deemed unrelated to the study drug. Importantly, no increased risk of thrombocytopenia or gastrointestinal adverse events was observed.

Strategic Response and Next Steps

"We are disappointed with the results of our Phase 2b trial, which were impacted by an unexpectedly high treatment effect in the vehicle arm and a high discontinuation rate in the active arms," said David Domzalski, CEO of VYNE. "Although we missed our F-VASI50 and F-VASI75 endpoints, we did see a meaningful reduction in the percent change from baseline in both F-VASI and T-VASI for our highest dose."

The company announced it will discontinue the ongoing extension phase of the trial and will not proceed with further internal development of Repibresib. Instead, VYNE will seek an external partner to continue advancing the asset. The company emphasized its ongoing confidence in its InhiBET(TM) BET inhibitor platform and plans to provide updates on its oral BET inhibitor, VYN202, in the coming weeks.

Financial Update

While full financial results for Q2 2025 have not yet been finalized, VYNE estimates it had approximately $39.6 million in cash, cash equivalents, and investments as of June 30, 2025.

The post VYNE Therapeutics Reports Disappointing Phase 2b Results for Repibresib Gel in Vitiligo Trial, Shares Drop 73% appeared first on PRISM MarketView.

COMTEX_467675108/2927/2025-07-30T12:01:26