BRIDGEWATER, N.J., Jan. 09, 2023 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that the first vitiligo patient has been dosed in a Phase 1a/b clinical trial of VYN201. VYN201 is a locally administered, small molecule, pan-bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immuno-inflammatory diseases. The clinical trial is a first-in-human study designed to generate safety and pharmacokinetic data in healthy volunteers (Phase 1a) as well as provide early clinical proof-of-concept data in vitiligo patients (Phase 1b).

“Dosing the first vitiligo patient in our Phase 1a/b clinical trial represents a significant clinical milestone for VYNE and our novel InhiBET™ BET inhibitor platform,” said David Domzalski, President and Chief Executive Officer of VYNE. “I’m pleased with the progress our team has made to advance this critical program, and we look forward to reporting topline data for both the Phase 1a and Phase 1b portions of the study in the first half of 2023.”

In the Phase 1b portion, up to 30 patients with a clinical diagnosis of non-segmental vitiligo will receive VYN201 once daily in up to three dose cohorts. The primary objective of the Phase 1b portion of the study will be to evaluate the safety and pharmacokinetics of VYN201. Exploratory efficacy of VYN201 in non-segmental vitiligo patients will also be evaluated, including pharmacodynamic biomarkers and photography.