Takeda’s Zasocitinib Delivers Landmark Phase 3 Success in Plaque Psoriasis, Setting Up Once-Daily Oral Rival to Biologics
Link: https://links.sgx.com/1.0.0/corporate-announcements/M8MPCA4LCZJOS352/f8e602516cd72f8580ec37a677f2e5a5b527ca9ec1bd18937e7214169d82a6c4
Summary:
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Pivotal Phase 3 trials of once-daily oral zasocitinib (TAK-279) in moderate-to-severe plaque psoriasis met all primary and 44 ranked secondary endpoints, including superiority to placebo and apremilast on key skin clearance measures.
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More than half of treated patients achieved clear or almost clear skin (PASI 90) and about 30% reached complete clearance (PASI 100) by week 16, with responses continuing to improve through week 24.
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Zasocitinib showed a generally well-tolerated safety profile consistent with earlier studies, with upper respiratory tract infection, nasopharyngitis and acne as the most common adverse events and no new safety signals.
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Takeda plans to file a New Drug Application with the U.S. FDA and other regulators starting in FY 2026, positioning the highly selective TYK2 inhibitor as a potential leading oral therapy across psoriasis and broader immune-mediated inflammatory diseases.
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The company is also advancing zasocitinib in head-to-head trials versus deucravacitinib in psoriasis and in Phase 3 psoriatic arthritis and Phase 2 inflammatory bowel disease studies, while stating that today’s readout does not change its FY2025/26 earnings guidance.