FMX114 is VYNE’s proprietary tofacitinib and fingolimod combination gel formulation

FMX114, a novel combination

FMX114 is designed to address both the source and cause of inflammation in atopic dermatitis by combining:

Tofacitinib, a Janus kinase (JAK) 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.1,2,3

FMX114 demonstrated positive Phase Ib safety and efficacy results in patients with atopic dermatitis, compared to vehicle control. Enrollment is complete in the Phase 2a segment of the study. Top line results are expected end of July/early August 2022.

1 Czeloth N, Bernhardt G, Hofman F, Genth H and Forster R, J Immunol, 2005 Sep; 175(5): 2960-2967
2 Allende ML, Sipe LM, Tuymetova G, Wilson-Henjum KL, Chen W and Proia RL, J Biol Chem. 2013 Jun 21; 288(25): 18381–18391
3 Tsuji T, Okuno S, Kuroda A, Hamazaki J, Chikami T, Sakurai S, Yoshida Y, Banno R, Fujita T and Kohno T, Allerg. Int., 2016; 65: 172-179