Takeda has announced positive topline results for the two Latitude Phase 3 active comparator-controlled studies of zasocitinib (TAK-279), a highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). The results showed that approximately 30 percent of patients achieved complete skin clearance (PASI 100) by week 16 and more than half reached near-complete clearance (PASI 90), states the company. All primary and 44 ranked secondary endpoints in patients with PsO were met. Zasocitinib was generally well-tolerated, and the safety and tolerability profile remained consistent with prior studies.

The Latitude Phase 3 psoriasis studies 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 (PsO).

The studies demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints, static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75, at week 16, with a significantly greater PASI 75 response rate seen from week 4 and continuing to increase through week 24.

The studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast, showing the potential of a once-daily pill to deliver complete skin clearance for patients with PsO.

Favorable safety and tolerability profile

Zasocitinib was generally well-tolerated. The safety and tolerability profile of zasocitinib in the Phase 3 studies remained consistent with prior studies, including the Phase 2b plaque psoriasis study. The most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals identified.

“Plaque psoriasis is a chronic, immune-mediated disease that can significantly impact patients’ quality of life. While treatment options have advanced, there is still a need for innovative approaches that offer sustained disease control and help alleviate the overall burden of disease. It is encouraging to see the Phase 3 data suggesting that highly selective inhibition of TYK2 may represent a relevant treatment pathway for people living with psoriasis, reflecting our ongoing efforts to address areas of unmet medical need,” said Saija Silvola, Nordic Medical Director at Takeda.

Takeda plans to submit a New Drug Application with the United States Food and Drug Administration and other regulatory authorities starting in fiscal year 2026.

Zasocitinib is also being evaluated in a head-to-head study against deucravacitinib in plaque psoriasis, Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease and ulcerative colitis, among other indications. Results from the Phase 3 studies have no significant impact on the full-year consolidated forecast for the fiscal year ending March 31, 2026.