Incyte hopes its cream can rise to the top

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After last year’s epacadostat blowup, Incyte’s topical version of ruxolitinib, the active ingredient of its approved drug Jakafi, is now the group’s brightest pipeline hope. However, this is not saying much, with EvaluatePharma sellside consensus predicting 2024 sales of just $74m. At least topical ruxolitinib keeps delivering, with positive phase II data in the skin disorder vitiligo helping drive Incyte's stock up 5% this morning. The company plans to start phase III development later this year, with a 1.5% once and/or twice-daily dose looking the most likely to move forward based on the results reported on Saturday at the World Congress of Dermatology. Topical ruxolitinib is already in two phase III studies in atopic dermatitis, True AD1 and True AD2, testing 1.5% and 0.75% twice daily. Several other topical Jak inhibitors are in trials in various autoimmune diseases, including Aclaris’s ATI-502, which is due to yield data from a phase II vitiligo study in mid-year – the company just reported phase II data with the project in alopecia. Topical ruxolitinib is not in development for alopecia, but CTP-543, Concert's deuterated version of ruxolitinib, is; however, Incyte is doing its best to get Concert’s patent invalidated.

24-week data with topical ruxolitinib in phase II vitiligo trial, NCT03099304
Endpoint 1.5% once daily 1.5% twice daily Vehicle
% of patients achieving F-VASI50* 50% 45% 3%
% of patients achieving F-VASI75 17% 30% 0%
% of patients with F-PhGVA clear/almost clear 13% 9% 0%
*Primary endpoint; F-VASI50: ≥50% improvement in facial vitiligo area severity index; F-VASI75: ≥75% improvement in facial vitiligo area severity index; F-PhGVA: facial physician global vitiligo assessment. Source: company release.

 

Selected topical Jak inhibitors in development
Project Company Indication(s) Mechanism Status
JTE-052/delgocitinib  Japan Tobacco, Torii Pharmaceutical Atopic dermatitis Jak inhibitor Filed (Japan)
Topical ruxolitinib/ INCB018424 Incyte Atopic dermatitis, vitiligo Jak 1 & 2 inhibitor Phase III
ATI-502 Aclaris Therapeutics Atopic dermatitis, alopecia, vitiligo Jak 1 & 3 inhibitor Phase II
CTP-543 Concert Pharmaceuticals Alopecia   Jak 1 & 2 inhibitor Phase II
SNA-125 Sienna Biopharmaceuticals Atopic dermatitis Trk A & Jak 3 inhibitor Phase II
Source: EvaluatePharma.

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