VYNE Therapeutics to Present VYN201 at 2024 SID Annual Meeting

VYNE Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing innovative therapies for immuno-inflammatory conditions, announced that two abstracts showcasing results for its novel BET inhibitor, VYN201, will be presented at the 81st Annual Meeting of the Society for Investigative Dermatology (SID) in Dallas, TX, from May 15-18, 2024. The company is keen to present both preclinical and Phase 1b data highlighting VYN201’s potential as a treatment for nonsegmental vitiligo.

Dr. Iain Stuart, Chief Scientific Officer of VYNE, expressed the company's enthusiasm for sharing their data with the scientific community. VYN201, designed to be a locally administered “soft” drug, targets diseases involving various inflammatory cell signaling pathways with minimal systemic exposure. Studies have shown that VYN201 not only demonstrates proof-of-concept in vitiligo but also reduces pro-inflammatory biomarkers and disease severity in multiple preclinical models.

The two selected abstracts detail the translational evaluation of VYN201 for nonsegmental vitiligo. The first presentation, scheduled for May 16, will discuss the preclinical studies, while the second presentation on May 18 will focus on Phase 1b data. Both sessions will be presented by Dr. Stuart and will reveal critical insights into the efficacy and safety of VYN201.

Vitiligo, a chronic autoimmune disorder characterized by the loss of pigment-producing cells called melanocytes, affects approximately 0.5-2.0% of the global population. Nonsegmental vitiligo is the most common form of this condition. Currently, there is only one FDA-approved treatment for vitiligo, highlighting an urgent need for new therapeutic options.

The Phase 1b study was conducted over 16 weeks with 29 patients who had active nonsegmental vitiligo. The trial evaluated the safety, tolerability, pharmacokinetics, and exploratory efficacy of a once-daily topical formulation of VYN201 across three concentration levels: 0.5%, 1.0%, and 2.0%. Significant clinical improvements were observed in the 1.0% and 2.0% cohorts, with a rapid onset of action and a dose-dependent response. Specifically, the mean percentage reduction in facial vitiligo area scoring index from baseline after 16 weeks was 7.5% for the 0.5% cohort, 30.2% for the 1.0% cohort, and 39.0% for the 2.0% cohort. VYN201 was generally well tolerated, with no significant adverse events reported.

BET inhibitors, like VYN201, function by regulating gene transcription through interactions with BET proteins, which play a crucial role in the activation of B cells and T cells, as well as subsequent inflammatory processes. By inhibiting these proteins, BET inhibitors can potentially treat a variety of immuno-inflammatory and fibrotic diseases, in addition to having potential applications in myeloproliferative neoplastic disorders.

VYNE Therapeutics is committed to improving patient outcomes by developing its proprietary bromodomain & extra-terminal (BET) domain inhibitors under the InhiBET™ platform. These include VYN201, which is administered locally, and VYN202, an orally available BD2-selective BET inhibitor. The company’s mission is to create innovative and differentiated therapies for immuno-inflammatory conditions.