Vyne Therapeutics’ combination therapy for atopic dermatitis failed to meet the primary endpoint in a Phase II trial, leaving the company evaluating its priorities and pipeline.
On Thursday, Vyne Therapeutics announced that its Phase IIA study of FMX114 failed to meet the primary endpoint when it was evaluated for patients with mild-to-moderate atopic dermatitis (AD). As a result, Vyne leadership will shine a magnifying glass on the pipeline.
Study VY2021-01 enrolled 21 patients with AD in the four-week Phase IIA treatment period, where each subject served as their own control. The randomized, double-blind trial compared the FMX114 gel’s efficacy and safety with a vehicle gel on lesions, which were treated twice a day.
FMX114 is an investigational combination of gel tofacitinib and fingolimod and is designed to address the source and the cause of inflammation in AD cases. Tofacitinib is a Janus kinase inhibitor that helps reduce inflammation in cells by inhibiting cytokines, while fingolimod is a Sphingosine 1-phosphate receptor modulator that works outside cells to quell inflammation by inhibiting the migration of inflammatory cells. If successful, FMX114 would have been the first topical combination medication for AD.
The primary endpoint was the absolute and percent change relative to baseline based on the Atopic Dermatitis Severity Index (ADSI). ADSI is made up of assessments of pruritus, erythema, exudation, excoriation and lichenification, each on a scale of 0 to 3. The maximum score is 15.
At week 4, the mean ADSI score for FMX114 users was 6.6, while those treated with vehicle gel scored 6.9 at baseline. The mean reduction in ADSI for the FMX114 group was -4.05 (-60.62%), while the vehicle group recorded a -3.48 (-51.32%) mean reduction. The study was conducted at sites in the United States and Australia, and all participants had to have at least two comparable target AD lesions upon enrollment.
“We’re obviously very disappointed by the outcome of this trial for FMX114. We will continue to thoroughly review the full data set and complete our analysis. In addition, as a result of this outcome, our management team and our board of directors will evaluate the Company’s pipeline and prioritization of activities,” David Domzalski, chief executive officer of Vyne said in a statement.
Vyne completed enrollment for this study segment in June when the company was highly encouraged by the early efficacy results from the trial’s Phase IB segment. Back then, two weeks’ worth of FMX114 treatment demonstrated statistically significant improvements in AD signs and symptoms along with positive pharmacokinetics and safety outcomes. FMX114 also showed the ability to reduce pruritus, based on the worst pruritus Numerical Rating Scale.
Atopic dermatitis is a chronic and severe type of eczema characterized by the appearance of red, dry and itchy skin typically on the arms, cheeks and legs. It can be triggered by several factors, including sweat, temperature changes, skin irritants, allergies and stress. The disease affects around 30 million people in the U.S. alone, and only about 22 million are in treatment. Topical medications can manage some cases, while others require antibiotic pills, anti-inflammatories and injectable biologics.
