InnoCare’s TYK2 Inhibitor Fadeucravacitinib Meets Phase 3 Psoriasis Endpoints

InnoCare Pharma’s oral TYK2 inhibitor fadeucravacitinib (ICP-488) has met the primary endpoint in a registrational Phase III trial for moderate-to-severe plaque psoriasis, demonstrating statistically significant and clinically meaningful improvement. The randomized, double-blind, placebo-controlled multicenter study also met multiple secondary endpoints, showing a consistent treatment effect across efficacy measures. Fadeucravacitinib exhibited a favorable safety profile consistent with previous clinical studies, with no new safety signals identified.

Fadeucravacitinib is an oral, potent and selective TYK2 allosteric inhibitor that binds to the JH2 domain, blocking signal transduction of IL-23, IL-12, type 1 interferons and other inflammatory cytokines, thereby inhibiting autoimmune and inflammatory disease processes. InnoCare is developing the drug for psoriasis, cutaneous lupus erythematosus (CLE), Sjögren’s syndrome, and other indications.

“Existing treatment options do not fully address the needs of psoriasis patients and there is a particularly high demand for novel oral therapies,” InnoCare’s CEO stated. The company plans to complete the Phase III study and advance regulatory filing to bring the drug to patients.

Psoriasis is a chronic, immune-mediated inflammatory skin disease characterized by erythematous plaques, scaling and systemic inflammatory involvement. Approximately 8.66 million people in China are currently living with psoriasis, and the number is rising, according to cited data. The global psoriasis treatment market is projected to reach about $57.7 billion by 2032.

InnoCare Pharma is a commercial-stage biopharmaceutical company with three approved drugs — orelabrutinib, tafasitamab and zurletrectinib — and more than ten innovative drug candidates in clinical development, focusing on cancer and autoimmune diseases.