InnoCare Pharma announced that its novel TYK2 inhibitor soficitinib has met the primary endpoint in a pivotal Phase III trial for the treatment of moderate-to-severe atopic dermatitis.

InnoCare Pharma (SSE: 688428; HKEX: 09969) today announced that its independently developed novel tyrosine kinase 2 (TYK2) inhibitor, soficitinib (ICP-332), has met the primary endpoint in a Phase III clinical trial for the treatment of moderate-to-severe atopic dermatitis (AD).

The Phase III clinical trial of soficitinib is a randomized, double-blind, placebo-controlled, multicenter pivotal study designed to evaluate the efficacy, safety, and tolerability of the drug in patients with moderate-to-severe atopic dermatitis.

Soficitinib met the primary endpoint in the pivotal Phase III clinical trial, demonstrating statistically significant and clinically meaningful improvement. The study also achieved multiple secondary endpoints, showing consistently significant therapeutic effects across all efficacy measures.

Soficitinib demonstrated a favorable safety profile consistent with previous clinical studies, and no new safety signals were identified. Detailed efficacy and safety data will be disclosed at international academic conferences and/or in international 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 Chief Executive Officer of InnoCare Pharma, stated: 'We are very pleased that the registrational Phase III trial of soficitinib in atopic dermatitis met its primary endpoint and demonstrated strong clinical efficacy. Atopic dermatitis is a chronic, relapsing inflammatory skin disease characterized by intense itching, eczema, and severely impaired quality of life, representing a significant unmet medical need. We will accelerate the completion of subsequent studies and promptly initiate regulatory submissions to bring a better treatment option to patients suffering from atopic dermatitis and other autoimmune conditions.'

According to the World Health Organization’s Global Burden of Disease Study, atopic dermatitis affects approximately 230 million people worldwide, making it the skin disease with the highest non-fatal disease burden globally [1]. In China, nearly 70 million individuals suffer from atopic dermatitis, and its prevalence continues to rise annually [2].

[1] Jiefang Daily - Shangguan News

[1] People's Daily Overseas Edition

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