VYNE Therapeutics Announces Positive Data from Phase 1b Trial for Novel BET Inhibitor VYN201 in Patients with Nonsegmental Vitiligo

• Clinical proof-of-concept achieved with statistically significant dose dependent reduction in F-VASI score from baseline for the VYN201 1.0% and 2.0% cohorts compared to the 0.5% cohort
• VYN201 was generally well-tolerated with no clinically relevant treatment emergent adverse events across all dose cohorts
• Clinical response and rapid onset of action suggest VYN201 has the potential to be the category leader in the treatment of nonsegmental vitiligo
• VYN201 is expected to advance into a Phase 2b clinical trial in the first half of 2024

BRIDGEWATER, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced positive data from its Phase 1b trial evaluating once-daily dosing of VYN201 in patients with nonsegmental vitiligo.

The Phase 1b trial is a 16-week open-label trial assessing the safety, tolerability and pharmacokinetics of once-daily topical VYN201 in 29 patients across three dose cohorts (0.5%, 1.0% and 2.0% strengths). Exploratory efficacy of VYN201 was also evaluated, including VYN201’s ability to arrest the progression of skin depigmentation and support skin repigmentation in patients with active disease, through changes in the facial vitiligo area scoring index (“F-VASI”).

“We are encouraged by these data from our Phase 1b trial that demonstrate proof-of-concept in nonsegmental vitiligo, which we believe is the first clinical evidence of a BET inhibitor’s effect in autoimmune disease. We believe these data support the continued advancement of VYN201 as a potential category leading therapy in the treatment of vitiligo and also more broadly validates our InhiBET platform as we work to develop BET inhibitors for the treatment of immuno-inflammatory diseases,” said David Domzalski, President and CEO of VYNE. “We look forward to discussing the final results from the trial at an R&D Day event on November 9, where we will also provide our plans for a Phase 2b clinical trial.”