VYNE says Phase IIa trial of FMX114 misses goal

Shares of US biopharma company VYNE Therapeutics (Nasdaq: VYNE) closed down 22.9% at $0.31 yesterday, having plunged as much as 35%, after it revealed results from the Phase IIa segment of a Phase Ib/IIa clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD) that failed to hit its goal.

Study VY2021-01 did not meet its primary endpoint based on the absolute and percent change relative to baseline in the Atopic Dermatitis Severity Index (ADSI). The Phase IIa study of FMX114 enrolled 21 patients and was designed to evaluate four weeks of FMX114 treatment in patients with mild-to-moderate AD compared to vehicle control. The enrollment criteria specified that subjects must have two comparable target AD lesions for treatment upon entry. Target lesions were randomized and treated twice daily with either FMX114 or vehicle gel.

The gel formulation combines the JAK inhibitor tofacitinib, which is marketed as mar Xeljanz by Pfizer (NYSE: PFE), with fingolimod, an S1P receptor agonist sold by Novartis under the Gilenya brand name.