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

  • Phase 1b/2a trial for FMX114 Complete:
    • On target PK and safety profile met
    • Statistically significant efficacy results at weeks 1, 2 and 3
    • Primary efficacy endpoint at week 4 not met but numerically superior
    • Continued effect demonstrated through week 6 (OLE)
  • FMX114 is Phase 2b ready

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