VYNE Therapeutics Inc. (NASDAQ: VYNE) shares took some time to get rolling Friday, as the biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, announced the completion of enrollment in the Phase 2a study of FMX114 for the treatment of mild-to-moderate atopic dermatitis (“AD”).
FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod, which has been designed to address both the source and cause of inflammation in AD.
Last April, VYNE reported positive efficacy data from the Phase 1b segment of the trial, demonstrating that treatment with FMX114 resulted in a statistically significant reduction in both absolute and percent change in mean Atopic Dermatitis Severity Index (“ADSI”) score compared to vehicle. FMX114 treatment also substantially reduced pruritus (itch) as measured on the worst pruritus Numerical Rating Scale.
The Phase 2a segment of the FMX 114 study is designed to evaluate four weeks of FMX114 treatment in patients with AD compared to vehicle control.
Due to the impact of COVID-19 on enrollment and other operations related to the original trial sites in Australia, the Company activated additional clinical trial sites in the United States to support patient enrollment and expedite completion of the study. With enrollment now completed, the Company expects to report top-line efficacy results in approximately six to eight weeks.
VYNE opened Friday unchanged at 51 cents.