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VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis
Top-line Efficacy Results Expected in Approximately 6 to 8 Weeks BRIDGEWATER, N.J., June 17, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE)
About this update from Vyne Therapeutics Inc.
[{"type":"text","content":"Top-line Efficacy Results Expected in Approximately 6 to 8 Weeks\nBRIDGEWATER, N.J., June 17, 2022 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today 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. In April 2022, 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 (“NRS”). 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 6 to 8 weeks. “We have been encouraged by the early efficacy results from the Phase 1b segment of the FMX114 trial showing that, based on ADSI scoring, two weeks of FMX114 treatment demonstrated a statistically significant improvement in the signs and symptoms of AD as well as acceptable safety and pharmacokinetics,” said David Domzalski, Chief Executive Officer of VYNE Therapeutics. “We look forward to reporting the results of the Phase 2a segment of the study in approximately 6 to 8 weeks.” About The FMX114 2a study (VY2021-01, ClinicalTrials.gov Identifier: NCT04927572)The Phase 2a segment of the study is a randomized, double-blinded trial, designed to compare the safety and efficacy of FMX114 gel with vehicle gel. The Phase 2a segment was designed to enroll up to 25 ...