Zasocitinib phase 3 plaque psoriasis data

[Fred]

Takeda’s Zasocitinib landmark phase 3 plaque psoriasis data show promise to deliver clear skin in a once-daily pill, catalyzing a new era of treatment.

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Takeda today announced positive topline results for the two pivotal Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled 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). 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 as early as 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 convenient once-daily pill to deliver complete skin clearance for patients with PsO.

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. “It is incredibly rewarding and exciting to see our Phase 2 results validated in Phase 3, with more than half of patients treated with zasocitinib achieving clear or almost clear skin (PASI 90) and about 30 percent achieving completely clear skin (PASI 100) at week 16, with response rates continuing to increase through week 24,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “These findings help demonstrate that highly selective inhibition of TYK2, a key mediator of IL-23 and other signaling pathways fundamental to psoriasis, may provide patients with significant reductions in their disease burden, including for many, the possibility of complete skin clearance.”

Takeda intends to present the results at upcoming medical congresses and 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 and psoriatic arthritis.

Source: takeda.com