VYNE THERAPEUTICS INC

VYNE Therapeutics completed enrollment for a Phase 2b trial of VYN201 gel for nonsegmental vitiligo treatment, with top-line data expected mid-2025. The USAN Council named the active ingredient 'repibresib'. The trial evaluates efficacy, safety, and pharmacokinetics of repibresib gel in three doses over 24 weeks, with an optional 28-week extension.

VYNE Therapeutics completed enrollment for a Phase 2b trial of VYN201 gel, now named repibresib, for nonsegmental vitiligo treatment. Top-line data expected mid-2025. Repibresib, a BET inhibitor, aims to treat chronic inflammatory conditions with low systemic exposure.

VYNE Therapeutics' VYN202, a novel BET inhibitor, shows promising PK, pharmacodynamic, and safety data in Phase 1a trials, indicating potential as a treatment for immune-mediated diseases. Designed to minimize adverse events, VYN202's selectivity and potency could offer a new non-biologic treatment option for chronic inflammatory conditions.

At Fall Clinical 2024, a poster presented the efficacy of VYN201, a topical BET inhibitor for active non-segmental vitiligo (aNSV), based on a phase 1b trial. The study confirmed safety and tolerability, with significant dose-dependent clinical responses in F-VASI scores after 16 weeks. Mild to moderate adverse effects were noted, but no serious events occurred. VYN201's potential extends beyond vitiligo to other dermatologic and immunologic diseases.

Phase III trials for Aravive’s batiraxcept in ovarian cancer and Travere’s Filspari in FSGS failed, reducing their LoA. VYNE’s VYN201 showed positive Phase Ib results in vitiligo. Moderna’s MEDI1191, Drug Farm’s DF-006, and Alexion’s ALXN-2220 completed Phase I trials, increasing their PTSR in solid tumors, hepatitis B, and ATTR-CM, respectively.