Takeda reported new Phase 3 data showing that its oral TYK2 inhibitor zasocitinib (TAK‑279) produced high rates of skin clearance across multiple difficult psoriasis sites, including the scalp, palms and soles, and nails, in adults with moderate‑to‑severe plaque psoriasis.
The results come from the pivotal, randomized, double‑blind, placebo‑ and active‑controlled LATITUDE PsO 3001 and 3002 trials. In patients with scalp involvement at baseline, 77% and 74% of those treated with zasocitinib achieved scalp‑specific PGA (ssPGA) 0/1 (clear or almost clear) at week 16, compared with 7% and 13% on placebo and 42% and 30% on apremilast. For palmoplantar disease, approximately 70% of zasocitinib‑treated patients reached hands/feet‑specific PGA (hfPGA) 0/1 at week 16 (71% and 69%), versus 22% and 10% with placebo and 44% and 43% with apremilast.
Zasocitinib also achieved statistically significant improvements in Nail Psoriasis Severity Index scores versus placebo at week 16, with responses across sites sustained through week 24. Earlier topline data from the same trials showed about 70% of patients reached static Physician Global Assessment 0/1 at week 16, with PASI 75 responses emerging by week 4 and increasing through week 24.
The most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals reported.
Takeda said it plans to submit a New Drug Application for zasocitinib in plaque psoriasis to the U.S. Food and Drug Administration and other regulators beginning this fiscal year. The drug is also in Phase 3 trials for psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa.
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