VYNE Therapeutics Begins Phase 2b Trial of VYN201 for Vitiligo

VYNE Therapeutics Inc., a clinical-stage biopharmaceutical company, has announced a significant development in its Phase 2b trial for VYN201, targeting nonsegmental vitiligo. Nonsegmental vitiligo is a prevalent autoimmune skin disorder characterized by the loss of pigment-producing cells, known as melanocytes. The trial aims to assess the effects of VYN201, a novel pan-bromodomain and extra-terminal domain (BET) inhibitor designed for localized administration, on patients experiencing either active or stable forms of this condition.

The Phase 2b trial has officially commenced with the dosing of the first subject. This trial adheres to a randomized, double-blind, vehicle-controlled design to ensure robust and unbiased results. It involves three different concentrations of the VYN201 topical gel (1%, 2%, and 3%), which will be applied once daily over a 24-week period. Approximately 160 subjects will participate, randomized in a 1:1:1:1 ratio to either the treatment or control groups. Following the initial 24 weeks, those in the active treatment arms will continue their regimen for an additional 28 weeks. In contrast, participants from the vehicle group will be re-randomized to receive one of the three concentrations of VYN201 for the same duration.

The primary endpoint of the trial is to determine the proportion of subjects achieving at least a 50% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI50) at the 24-week mark. Secondary endpoints include assessments of both F-VASI and Total VASI (T-VASI) at 24 and 52 weeks. This rigorous evaluation aims to provide a comprehensive understanding of VYN201's therapeutic potential.

David Domzalski, President and CEO of VYNE, emphasized the importance of this milestone. He cited the promising results from a prior Phase 1b trial, where VYN201 exhibited a significant clinical response, rapid onset of action, and a favorable safety profile with minimal systemic exposure. Domzalski expressed optimism about VYN201's potential to become a valuable treatment for vitiligo, with top-line data from the current trial expected in mid-2025.

Vitiligo is the most common depigmenting skin condition, affecting 0.5-2.0% of the global population. Despite its prevalence, there is currently only one FDA-approved treatment for vitiligo, highlighting the significant unmet medical need that VYN201 aims to address.

VYN201 is part of VYNE's InhiBET™ platform, which includes innovative BET inhibitors developed to tackle various inflammatory diseases. BET proteins are crucial in regulating gene transcription and inflammatory processes. By inhibiting these proteins, VYN201 and similar drugs have the potential to mitigate the effects of multiple inflammatory and fibrotic conditions.

VYNE Therapeutics Inc. is dedicated to improving patient lives through the development of proprietary therapies for immuno-inflammatory conditions. Their portfolio includes both locally administered and orally available BET inhibitors, licensed from Tay Therapeutics Limited, aimed at providing differentiated treatment options for patients.

The company remains focused on advancing its clinical programs and looks forward to the forthcoming data, which could potentially redefine the therapeutic landscape for vitiligo patients.