Takeda Reports Positive Phase 3 Results for Oral TYK2 Inhibitor Zasocitinib

Key Takeaways

• Takeda reported positive topline results from the Phase 3 LATITUDE Atlas trial, demonstrating superiority of zasocitinib over deucravacitinib in moderate-to-severe plaque psoriasis.
• Zasocitinib achieved significantly higher rates of complete skin clearance (PASI 100) at week 16, meeting the study’s primary endpoint.
• Takeda plans to submit a New Drug Application for zasocitinib beginning this fiscal year.

Takeda announced positive topline results from the Phase 3 LATITUDE Atlas (TAK-279-PsO-3004) trial, a head-to-head study evaluating the investigational oral tyrosine kinase 2 (TYK2) inhibitor zasocitinib (TAK-279) against deucravacitinib in adults with moderate-to-severe plaque psoriasis.

The randomized, multicenter, double-blind study met its primary endpoint, with zasocitinib demonstrating statistical superiority to deucravacitinib in achieving complete skin clearance, as measured by Psoriasis Area and Severity Index (PASI) 100 response at Week 16. The investigational therapy also achieved statistical superiority across all key secondary endpoints, including PASI 90 response and Static Physician’s Global Assessment (sPGA) 0 at Week 16.

According to Takeda, more than 35% of patients treated with zasocitinib achieved PASI 100 at Week 16, representing more than 2.5 times the response rate observed with deucravacitinib. The company also reported separation between treatment curves as early as Week 8. Zasocitinib was generally well tolerated, with a safety profile consistent with previous studies and no new safety signals identified.

“In this head-to-head study, zasocitinib clearly demonstrated superior skin clearance compared with deucravacitinib, highlighting clinically meaningful differences within the oral treatment class,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health and principal investigator for the LATITUDE Atlas study. “As expectations for oral therapies continue to rise, these findings support the potential of zasocitinib to help transform what patients and physicians can expect from an oral option in plaque psoriasis.”

Head-to-Head TYK2 Inhibitor Data Strengthen Zasocitinib Regulatory Case

“These head-to-head results build on the strong efficacy seen across our Phase 3 program,” said Chinwe Ukomadu, MD, PhD, senior vice president and head of Takeda’s Gastrointestinal & Inflammation Therapeutic Area Unit. “Together, these findings reinforce the promise of zasocitinib to deliver rapid and durable skin clearance in a convenient once-daily pill and demonstrate the transformative potential of highly selective and potent TYK2 inhibition for patients suffering with plaque psoriasis.”

Takeda said detailed data from LATITUDE Atlas will be presented at upcoming medical meetings. The results build on findings from the Phase 3 LATITUDE PsO 3001 and 3002 studies presented earlier this year at the American Academy of Dermatology Annual Meeting. The company remains on track to submit a New Drug Application for plaque psoriasis to the US Food and Drug Administration and other regulatory authorities beginning this fiscal year.