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VYNE Therapeutics Enrolls First Patient in Clinical Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis
Important milestone achieved as part of the Company’s new corporate strategy to develop treatments for immuno-inflammatory diseases Topline results
About this update from Vyne Therapeutics Inc.
[{"type":"text","content":"Important milestone achieved as part of the Company’s new corporate strategy to develop treatments for immuno-inflammatory diseases Topline results anticipated in early Q1 2022 BRIDGEWATER, N.J., Oct. 19, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that it has enrolled the first patient in its Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD). FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed to address both the source and cause of inflammation in AD by developing a distinct combination of tofacitinib (a Janus kinase inhibitor aimed at reducing inflammation by inhibiting cytokine release from inflammatory cells) and fingolimod (a Sphingosine 1-phosphate receptor modulator) which approaches the reduction of inflammation by inhibiting migration of inflammatory cells, and in addition may also directly support skin barrier recovery. FMX114 has the potential to be the first topical combination JAK inhibitor for the treatment of AD as well as the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor mode of action. The planned 25 patient Phase 2a study comparing the safety and efficacy of FMX114 gel with vehicle gel will also incorporate a preliminary Phase 1b evaluation of the safety and pharmacokinetics of FMX114 in 6 patients with mild to moderate atopic dermatitis for up to two weeks. Dr. Iain Stuart, Chief Scientific Officer of VYNE, stated, “With FMX114, VYNE is further leveraging our extensive drug development capabilities by providing another unique targeted therapy with difficult-to-formulate active ingredients. FMX114 has been specifically designed to mitigate systemic exposure to tofacitinib and fingolimod while concentrating their respective anti-inflammatory and barrier repair properties in the skin. In light of the FDA’s recent review of the oral JAK inhibitor class for the treatment of several systemic autoimmune diseases, we believe it’s important to characterize the preliminary safety and pharmacokinetic profile of FMX114. The Phase 1b portion of the study will generate meaningful data as we advance the product into the Phase 2a portion for broader safety and efficacy evaluatio...