Takeda announced positive Phase 3 results for zasocitinib showing rapid and durable skin clearance in moderate-to-severe plaque psoriasis patients with a consistent safety profile.
Key takeaways
71.4% and 69.2% of zasocitinib patients achieved sPGA 0/1 at week 16 versus 10.7%-12.6% placebo and 29.7%-32.1% apremilast (p<0.001).
61.3% and 51.9% achieved PASI 90 at week 16 versus 4.0%-5.0% placebo and 15.9%-16.8% apremilast (p<0.001).
39.9% and 33.7% achieved sPGA 0 at week 16 versus 0.7%-1.4% placebo and 6.5%-8.0% apremilast (p<0.001).
16.8% zasocitinib patients achieved PASI 75 at week 4 versus 4.3% placebo (p<0.001).
TEAEs through week 16 were 62.1% for zasocitinib versus 46.9% placebo and 50.5% apremilast; most common were upper respiratory tract infection (10.1%), nasopharyngitis (6.2%), acne (6.5%).
Takeda plans NDA submissions starting fiscal year 2026; results have no significant impact on FY ending March 31, 2026 forecast.