A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.
Incyte has FDA approval for Opzelura, which inhibits all JAKs and TYK2, in the autoimmune skin disorder vitiligo. Developers of TYK2 inhibitors have recognized the opportunity, with Takeda running a phase 2 trial of zasocitinib in the indication and InnoCare assessing soficitinib in a phase 2/3 study. Researchers are testing Bristol Myers Squibb’s Sotyktu in the indication in a midphase investigator-initiated study.
Thursday, InnoCare furthered its pursuit of the market by publishing topline data from the phase 2 part of its trial. Run from sites in China, the study evaluated the effect of 24 weeks of daily oral dosing on the Facial Vitiligo Area Scoring Index (F-VASI), a measure of disease severity.
At Week 24, F-VASI changed by 41.2% on the high dose of soficitinib, compared to 38.8% on the low dose and 2.2% on placebo. Both soficitinib doses performed significantly better than placebo, achieving the trial’s primary endpoint.
InnoCare has yet to share further efficacy data, and only provided a high-level overview of its safety and tolerability results. The safety profile was favorable and consistent with previous studies, the company said. Soficitinib was reportedly well tolerated and no new safety signals were uncovered. InnoCare plans to share detailed safety and efficacy results at a scientific congress or in an academic journal.
The phase 2/3 vitiligo study is part of a multi-front push to explore the potential of soficitinib, also called ICP-332. InnoCare is running mid- to late-phase trials in atopic dermatitis, chronic spontaneous urticaria, plaque psoriasis and prurigo nodularis.
In parallel, the biotech is testing another TYK2 drug candidate, ICP-488, in a phase 2 cutaneous lupus erythematosus trial and a phase 3 plaque psoriasis study. Soficitinib is a TYK2 JH1 inhibitor, while ICP-488 binds the JH2 domain. Meanwhile, BMS’ Sotyktu and Takeda’s zasocitinib bind JH2.