Clinical Pipeline > FMX114*
tofacitinib and fingolimod combination gel formulation being investigated for the treatment of mild to moderate atopic dermatitis in patients 12 years of age and older.
Atopic dermatitis (AD) is a chronic, severe form of eczema that is characterized by the appearance of dry, red, and itchy skin. AD most commonly affects the cheeks, arms, and legs. Flare ups can happen and symptoms can worsen leading to more-intense itching and more open sores. AD flares are triggered by stress, temperature changes, sweat, various skin irritants, and allergies.1 While AD happens most often in children, it can develop at any point in a person’s lifetime and affects over 30 million people in the U.S. 22 million of those diagnosed are on treatment with 19 million registering mild to moderate disease.4 The rashes tend to flare and go away, but then come back again which may impact self-esteem and quality of life.5 Although there is no cure for atopic dermatitis, it is not contagious and treatments are available.1,3
Early-stage development of a topical tofacitinib, fingolimod fixed-dose combination
FMX114 is VYNE’s proprietary tofacitinib and fingolimod combination gel formulation under investigation for the treatment of mild to moderate atopic dermatitis. FMX114 attempts 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 (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.6,7,8
A proof of concept study was conducted with FMX114 in a well-known animal model of AD. 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 dinitrochlorobenzene (DNCB) 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 DNCB control group at Day 7, and both FMX114 doses had comparable efficacy to triamcinolone 0.1% cream.
Development milestones include:
- Initiation of Phase 2a Study in Q3 2021
- Topline results anticipated by end 2021
*The safety and efficacy of FMX114 has not been established and there is no guarantee that it will receive health authority approval or become commercially available.
†mADI is a composite mean score of erythema, excoriation/erosion and xerosis/peeling severity scored on a 4-point ordinal scale per domain (0=none, 1=mild, 2=moderate and 3=severe for a maximum score of 9), data expressed as a mean percentage change from initiation of treatment phase.
- Data on File at VYNE Therapeutics Inc. Bridgewater, NJ.
- Anderson RT, Rajagopalan R. Effects of allergic dermatosis on health-related quality of life. Curr Allergy Asthma Rep. 2001;1(4):309-315.
- Schwartz DM, Kanno Y, Villarino A, Ward M, Gadina M and O’Shea JJ, Nat Rev Drug Discov. 2017 Dec 28; 17(1):78.
- Czeloth N, Bernhardt G, Hofman F, Genth H and Forster R, J Immunol, 2005 Sep; 175(5): 2960-2967.
- Allende ML, Sipe LM, Tuymetova G, Wilson-Henjum KL, Chen W and Proia RL, J Biol Chem. 2013 Jun 21; 288(25): 18381–18391 and data on file at VYNE.