Phase 2a FMX114 Study for AD Did Not Meet Primary Endpoints

VYNE Therapeutics, a biopharmaceutical company that develops therapies for immuno-inflammatory conditions, announced the phase 2a section of the phase 1b/2a clinical trial monitoring FMX114 gel for the treatment of mild-to-moderate atopic dermatitis (AD) did not meet its primary endpoints.

Study VY2021-01 did not meet its endpoint of improving symptoms and severity of AD based on the absolute and percent change relative to the baseline in the Atopic Dermatitis Severity Index (ADSI). According to David Domzalski, CEO of Vyne Therapeutics, the company will closely review the data to complete their analysis and rediscuss their pipeline.¹

Just over 20 patients were enrolled in the phase 2a study, which was designed to monitor 4 weeks of FMX114 treatment in patients with mild-to-moderate AD. To qualify for enrollment, patients had to show proof of 2 comparable target AD lesions for treatment. Target lesions were selected randomly and treated twice per day with FMX114 or vehicle.

The efficacy of phase 2a was concluded based on the absolute and percent change related to baseline in the ADSI scoring after week 4. The mean ADSI scores for FMX114 and vehicle treated lesions were 6.6 and 6.9 at baseline. The mean reduction in ADSI score from baseline was -4.05 (-60.62% mean reduction) for FMX114 treated lesions compared to -3.48 (-51.32% mean reduction) for vehicle treated lesions at week 4 (P=.228, OC, ITT).

The phase 2a section of VY2021-01 was a randomized, double-blind clinical trial designed to compare the safety and efficacy of FMX114 gel and a vehicle gel. Initially, phase 2a was intended to enroll up to 25 patients, with each patient acting as their own control. Both the phase 1b and 2a study required patients to have 2 comparable target AD lesions. After phase 2a, patients would have been eligible to participate in a 2-week open label treatment phase with the active drug applied to both lesions.

Reference:

1. VYNE Therapeutics announces results from its phase 2a trial of FMX114 for the treatment of mild-to-moderate atopic dermatitis – VYNE Therapeutics. Accessed August 10, 2022. https://vynetherapeutics.com/press-releases/vyne-therapeutics-announces-results-from-its-phase-2a-trial-of-fmx114-for-the-treatment-of-mild-to-moderate-atopic-dermatitis/