Takeda Pharmaceutical Company Limited announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). These data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies. In the Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled Latitude PsO 3001 and 3002 studies, more than half of patients treated with zasocitinib achieved clear or almost clear skin at week 16, a key measure of treatment success: 71.4% and 69.2% of patients treated with zasocitinib achieved a static Physician Global Assessment (sPGA) score of 0/1 versus placebo (10.7% and 12.6%) and apremilast (32.1% and 29.7%) at week 16.
About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies. A significantly greater PASI 75 response rate versus placebo was observed as early as week 4. Safety profile consistent with Phase 2b studies with no new safety signals identified. Zasocitinib is an investigational, next-generation, highly selective oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways.
It has the potential to be a leading oral treatment option for people living with immune-mediated inflammatory diseases. Zasocitinib has more than 1-million-fold greater selectivity for TYK2 compared to other JAK enzymes, which could maximize TYK2 inhibition without impacting JAK1, 2 and 3 signaling, based on in vitro data. Takeda is currently evaluating the safety and efficacy of zasocitinib in a head-to-head study against deucravacitinib in plaque psoriasis and in Phase 3 studies in psoriatic arthritis.
In addition, Phase 2 studies are ongoing in Crohn?s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS). Zasocitinib is an investigational compound that has not been approved for use by any regulatory authority. The Latitude Phase 3 psoriasis studies (NCT06088043 and NCT06108544) are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies to evaluate the efficacy, safety and tolerability of zasocitinib in adult patients with moderate-to-severe plaque psoriasis.
The studies were conducted in 21 countries and enrolled 693 and 1,108 participants, respectively. The co-primary endpoints were the proportion of zasocitinib-treated patients achieving sPGA 0/1 and PASI 75 response compared to placebo at week 16. Ranked (key) secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24).
