Why VYNE Therapeutics Is Skyrocketing
- VYNE Therapeutics Inc announced that the first vitiligo patient had been dosed in a Phase 1a/b trial of VYN201, a locally administered, small molecule, pan-bromodomain and extra-terminal domain (BET) inhibitor for immuno-inflammatory diseases.
- The clinical trial is a first-in-human study designed to generate safety and pharmacokinetic data in healthy volunteers (Phase 1a) and provide early clinical proof-of-concept data in vitiligo patients (Phase 1b).
- The company expects topline data for Phase 1a and Phase 1b parts 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.
- The exploratory efficacy of VYN201 in non-segmental vitiligo patients will also be evaluated, including pharmacodynamic biomarkers and photography.
- In August, VYNE Therapeutics announced results from the Phase 2a segment of a Phase 1b/2 trial of FMX114 for mild-to-moderate atopic dermatitis (AD), missing the primary endpoint of the disease severity index.
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