InnoCare Pharma Announces Phase II Study of Novel TYK2 Inhibitor Soficitinib in Vitiligo Meets Primary Endpoint

InnoCare Pharma (SSE: 688428; HKEX: 09969) announced that the Phase II portion of its Phase II/III study evaluating soficitinib (ICP-332), a next-generation oral TYK2 inhibitor independently developed by the company, in adults with non-segmental vitiligo has met its primary endpoint.

This is a Phase II/III, randomized, double-blind, placebo-controlled, parallel-group, adaptive, multicenter clinical trial designed to evaluate the efficacy and safety of soficitinib in patients with non-segmental vitiligo. The study consists of two stages: an initial Phase II followed by a Phase III.

Phase II results showed that at week 24, the Facial Vitiligo Area Scoring Index (F-VASI) demonstrated significant improvement from baseline: the once-daily 80 mg soficitinib group showed a 38.8% reduction from baseline, the 120 mg once-daily group showed a 41.2% reduction, compared to only a 2.2% reduction in the placebo group. The differences between both soficitinib dose groups and the placebo group were statistically significant (P<0.0001).

Soficitinib demonstrated a favorable safety profile consistent with previous clinical studies, was generally well tolerated, and no new safety signals were observed. Detailed efficacy and safety data will be presented at international scientific conferences and/or published in peer-reviewed journals.

Soficitinib is a novel, highly potent and selective oral TYK2 inhibitor independently developed by InnoCare Pharma for the treatment of multiple T-cell-mediated autoimmune diseases. Its current development pipeline focuses extensively on dermatology—a large and underserved market—including indications such as atopic dermatitis, vitiligo, prurigo nodularis, urticaria, and psoriasis. TYK2, a member of the Janus kinase (JAK) family, is a key kinase in the JAK-STAT signaling pathway and plays a critical role in inflammatory pathogenesis.

Dr. Jasmine Cui, Co-founder, Chairperson, and CEO of InnoCare Pharma, said, 'We are very pleased that the Phase II clinical study of soficitinib in vitiligo has met its primary endpoint. As a next-generation oral TYK2 inhibitor, soficitinib holds promise as an innovative treatment option for vitiligo patients, offering potentially improved efficacy, enhanced safety, and greater convenience in dosing.'

Vitiligo is a condition caused by the destruction of melanocytes in the skin, leading to a deficiency of melanin and resulting in localized white patches. The global prevalence of vitiligo is approximately 0.5% to 2% [1]. Vitiligo is a chronic disease requiring long-term treatment. The goals of vitiligo therapy are to control the progression of skin lesions, promote repigmentation of depigmented areas, and maintain treatment to prevent further depigmentation.

[1] Shanghai Municipal Health Commission

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