InnoCare Pharma's novel TYK2 inhibitor fadeucravacitinib (ICP-488) met the primary endpoint in its Phase III registrational study for psoriasis

InnoCare Pharma (SSE: 688428; HKEX: 09969) today announced that its independently developed novel TYK2 inhibitor, fadeucravacitinib (ICP-488), has met the primary endpoint in a Phase III registrational clinical trial for moderate-to-severe plaque psoriasis.

This Phase III registrational clinical study is a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, and tolerability of fadeucravacitinib in patients with moderate-to-severe plaque psoriasis.

The results showed that fadeucravacitinib met the primary endpoint of the Phase III registrational clinical study, demonstrating highly statistically significant and clinically meaningful improvement. The study also achieved multiple secondary endpoints, consistently showing significant therapeutic effects across all efficacy assessment measures.

Regarding safety, the safety profile of fadeucravacitinib was 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.

Fadeucravacitinib is an orally administered, highly selective allosteric inhibitor of TYK2. It specifically binds to the TYK2 JH2 domain, thereby blocking signal transduction of inflammatory cytokines such as IL-23, IL-12, and type I interferons, ultimately inhibiting the pathological processes of autoimmune and inflammatory diseases. Current indications under development include psoriasis, cutaneous lupus erythematosus (CLE), and Sjögren’s syndrome (SS)—all autoimmune conditions.

Dr. Jasmine Cui, Co-founder, Chairperson, and Chief Executive Officer of InnoCare Pharma, stated: 'We are delighted that the pivotal Phase III trial of fadeucravacitinib in psoriasis has met its primary endpoint, demonstrating outstanding clinical efficacy. Current treatment options fail to adequately address the needs of psoriasis patients, leaving a significant unmet demand—particularly for novel oral therapies. We will accelerate subsequent research activities and promptly initiate regulatory submission to provide patients with autoimmune diseases like psoriasis a more effective, safe, and convenient new treatment option.'

Psoriasis is an immune-mediated disease characterized by systemic inflammation that leads to raised, scaly plaques on the skin. Typical clinical manifestations include scaly plaques that may be localized or widely distributed across the body, making treatment challenging. The global psoriasis therapeutics market is projected to reach approximately USD 57.7 billion by 2032.[1] China is estimated to have around 8.66 million psoriasis patients,[2] with prevalence showing an upward trend.[3]

[1] Fortune Business Insights

[2] Epidemiological Burden Analysis of Psoriasis in China Based on Global Burden of Disease (GBD) Data [J]. Chinese Journal of Dermatology and Venereology, 2021.

[3] Advances in Epidemiological Studies on Psoriasis, Theory and Practice of Diagnostics, 2021.

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