Cambridge, Mass. — Takeda said its investigational oral TYK2 inhibitor zasocitinib significantly outperformed deucravacitinib in a head-to-head Phase 3 study of adults with moderate-to-severe plaque psoriasis.
The company said the randomized, multicenter, double-blind LATITUDE Atlas study showed once-daily zasocitinib, also known as TAK-279, was statistically superior to deucravacitinib across all primary and key secondary endpoints.
Zasocitinib met the primary endpoint of Psoriasis Area and Severity Index 100 response rate at week 16, a measure of complete skin clearance. Takeda said more than 35% of patients treated with zasocitinib achieved PASI 100 at week 16, more than 2.5 times the response rate seen with deucravacitinib.
The study also showed statistical superiority for key secondary endpoints, including PASI 90 response and Static Physician’s Global Assessment 0 at week 16.
Takeda said zasocitinib was generally well tolerated, with a safety and tolerability 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, M.D., 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.”
Chinwe Ukomadu, MD, PhD, senior vice president and head of Takeda’s Gastrointestinal & Inflammation Therapeutic Area Unit, said the results build on efficacy data from the company’s Phase 3 program.
“These head-to-head results build on the strong efficacy seen across our Phase 3 program, with more than 35% of zasocitinib-treated patients achieving complete skin clearance (PASI 100) at week 16 – more than 2.5 times the response rate for deucravacitinib – and separation from the deucravacitinib curve as early as week 8,” said Ukomadu. “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 it plans to present detailed data from the head-to-head study at upcoming medical congresses. The company also said it remains on track to submit a New Drug Application for plaque psoriasis to the U.S. Food and Drug Administration and other regulatory authorities starting this fiscal year.
Psoriasis is a chronic, systemic immune-mediated inflammatory disease marked by itchy, painful and disabling skin lesions that can affect physical, emotional and psychological well-being. About 64 million people worldwide are living with psoriasis, and roughly 80% to 90% of them have plaque psoriasis.
Zasocitinib is an investigational, next-generation, highly selective and potent oral TYK2 inhibitor designed to maintain 24-hour inhibition of IL-23 and other immune pathways involved in disease. Takeda said the drug has more than 1-million-fold greater selectivity for TYK2 compared with other JAK enzymes, based on in vitro data.
Takeda is also evaluating zasocitinib in Phase 3 studies for psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa.
Zasocitinib has not been approved for use by any regulatory authority.
