OTTAWA (dpa-AFX) - Takeda Canada, Inc., a Canadian subsidiary of Japan's Takeda Pharmaceutical Co. Ltd. (TAK), announced Tuesday positive topline results for the Phase 3, randomized, multicenter, double-blind study comparing zasocitinib (TAK-279) to deucravacitinib in adults with moderate-to-severe plaque psoriasis (PsO).
Zasocitinib is an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor.
In the LATITUDE Atlas (TAK-279-PsO-3004) head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, Psoriasis Area and Severity Index (PASI) 100 response rate at week 16.
More than 35% of zasocitinib-treated patients achieved complete skin clearance (PASI 100) at week 16 - more than 2.5 times the response rate for deucravacitinib.
The study also demonstrated statistical superiority over deucravacitinib for all key secondary endpoints, including PASI 90 response and Static Physician's Global Assessment (sPGA) 0 at week 16.
Zasocitinib was generally well tolerated with a consistent safety and tolerability profile and no new safety signals identified. The study was conducted across eight countries and enrolled 606 participants, including 73 patients across 18 sites in Canada.
The company said it is on track to submit a New Drug Application for plaque psoriasis with the U.S. Food and Drug Administration and other regulatory authorities starting this fiscal year.
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