VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company"), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today provided a program update for VYN202 following the clinical hold issued by the U.S. Food and Drug Administration (FDA) in April for the Company's Phase 1b clinical trial in the treatment of moderate-to-severe plaque psoriasis. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immune-mediated diseases.   

VYN202 Program Update

In April, the FDA placed a clinical hold on the Company's Phase 1b trial following an observation of testicular toxicity in dogs from a non-clinical toxicology study of VYN202. A No-Observed-Adverse-Effect Level (NOAEL) was established covering all clinical doses in females. The FDA has lifted the clinical hold for female patients on the 0.25 mg and 0.5 mg doses in this Phase 1b psoriasis trial. The 1 mg dose was not included at this time in the revised protocol submitted to the FDA due to its lower toxicological safety margin as compared to the 0.25 mg and 0.5 mg doses. Sufficient data from a 12-week non-clinical toxicology study of VYN202 in dogs would be required in order to resume the trial in male clinical subjects, and the design of this toxicology study has been agreed upon with the FDA.

Following the clinical hold, VYNE made the decision to unblind the clinical data from the subjects who were enrolled in the study (VYN202 treated: n=6 across 0.25 mg, 0.5 mg and 1 mg doses; Placebo treated: n=1).

The Company believes that the totality of the data from this study, together with promising results from multiple preclinical models, support the continued advancement of VYN202 into serious, immune-mediated diseases with limited effective treatment options. Based on this assessment, the Company will no longer enroll patients in the Phase 1b psoriasis study, extending the Company's expected cash runway into the fourth quarter of 2026. VYNE expects to provide further updates on its plans for the VYN202 program following the release of top-line results from the ongoing Phase 2b study of its lead candidate repibresib gel (formerly VYN201), a pan-BD BET inhibitor, for the treatment of non-segmental vitiligo.