Vyne Therapeutics Inc. plans to move forward on development of its fixed combination of pan-JAK inhibitor tofacitinib and sphingosine 1-phosphate receptor modulator fingolimod in a topical gel for mild-to-moderate atopic dermatitis. A phase 2a proof of concept study for FMX114 is planned to start in Q3 2021.

“We are excited to announce Vyne's newest therapeutic candidate FMX114,” says David Domzalski, Chief Executive Officer of Vyne. “FMX114 is a non-steroidal topical treatment that is designed to address the multi-factorial nature of AD by offering a fixed combination multimodal solution to disease management. Advancement of FMX114 supports our strategic objective of building a diversified pipeline of products to address unmet needs of patients. We look forward to initiating the planned Phase 2a clinical trial in Q3 this year with anticipated top-line results by year end.”

FMX114 was evaluated in a well-known nonclinical model of AD in which two doses of FMX114 (0.6% tofacitinib + 0.01% fingolimod and 0.3% tofacitinib + 0.02% fingolimod) were compared with tofacitinib monotherapy, fingolimod monotherapy, triamcinolone (steroid) 0.1%, and control. Treatment with FMX114 0.6% tofacitinib + 0.01% fingolimod combination gel resulted in an 89% reduction in the modified atopic dermatitis index score (mADI) relative to the control group at day 7. Both FMX114 doses had comparable efficacy to triamcinolone 0.1% cream.