Takeda Pharmaceutical Company (NYSE:TAK) has announced positive topline results from its two pivotal Phase 3 trials evaluating zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis.
The trials demonstrated the superior efficacy of zasocitinib compared to both placebo and active comparator apremilast, with significant improvements in the co-primary endpoints: static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 at 16 weeks.
Notably, PASI 75 responses were evident as early as week 4, continuing to improve through week 24.
Takeda’s zasocitinib also met all 44 ranked secondary endpoints, including PASI 90, PASI 100, and sPGA 0, reinforcing its potential to offer complete skin clearance for psoriasis patients.
The results, which underscore the potential of a once-daily pill, align with the increasing demand for oral treatments that provide faster, more effective relief for psoriasis patients.
Meanwhile, the safety profile of zasocitinib remained consistent with earlier studies, including the Phase 2b psoriasis trial, with the most common adverse events being upper respiratory tract infection, nasopharyngitis, and acne.
There were no new safety signals identified.
Takeda plans to submit a New Drug Application (NDA) for zasocitinib to the U.S. Food and Drug Administration (FDA) and other global regulatory bodies beginning in fiscal year 2026.
Zasocitinib is also under investigation in other trials for psoriatic arthritis, Crohn’s disease, and ulcerative colitis, among other indications.