Takeda Pharmaceutical Company Limited announced that its investigational drug zasocitinib (TAK-279) demonstrated statistical superiority over Bristol-Myers Squibb Co.'s Sotyktu (deucravacitinib) in the Phase 3 LATITUDE Atlas head-to-head study involving adults with moderate-to-severe plaque psoriasis. The primary endpoint of Psoriasis Area and Severity Index (PASI) 100 response rate at week 16 was met, along with all key secondary endpoints, including PASI 90 response and Static Physician's Global Assessment (sPGA) 0 at week 16. The drug was generally well tolerated with no new safety signals identified.

The LATITUDE Atlas (TAK-279-PsO-3004) study was a randomized, multicenter, double-blind trial comparing zasocitinib, a next-generation oral tyrosine kinase 2 (TYK2) inhibitor, to deucravacitinib. Results indicated that more than 35% of patients treated with zasocitinib achieved complete skin clearance (PASI 100) at week 16, which was more than 2.5 times the response rate observed for deucravacitinib. Separation from the deucravacitinib curve was evident as early as week 8.

Key Study Findings

Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health and principal investigator for the study, noted that the results highlight clinically meaningful differences within the oral treatment class. Chinwe Ukomadu, MD, PhD, senior vice president and head of the Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda, emphasized that the findings reinforce the potential of zasocitinib to deliver rapid and durable skin clearance.

AI-Developed Drug Targets Multi-Billion-Dollar Opportunity

Zasocitinib was developed using artificial intelligence, highlighting the pharmaceutical industry's increasing use of AI to accelerate drug development, streamline clinical trials, and reduce reliance on animal testing. Takeda stated that, if approved, zasocitinib could achieve peak annual sales of $3 billion to $6 billion.

Takeda intends to present detailed data from the head-to-head study at upcoming medical congresses. These results build on previously presented Phase 3 LATITUDE PsO data from studies 3001 and 3002. The company remains on track to submit a New Drug Application for plaque psoriasis with the United States Food and Drug Administration and other regulatory authorities starting this fiscal year.

Takeda announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for intravenous ENTYVIO (vedolizumab) for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn's disease in pediatric patients ages 2 years and older. If approved, ENTYVIO would be the only gut-focused treatment option for these patients, addressing unmet needs in pediatric gastroenterology. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the first quarter of calendar year 2027.

The sBLA submission is supported by data from two randomized, double-blind, multicenter Phase 3 pediatric trials: the KEPLER study in UC and the ongoing WEBB study in Crohn's disease. The primary endpoint for KEPLER was clinical remission at Week 54 among patients who achieved a clinical response following vedolizumab IV induction, while WEBB had co-primary endpoints of clinical remission and endoscopic response at Week 54.

Regulatory Submissions and Trial Details

Takeda has also submitted a marketing authorization application (MAA) to the European Medicines Agency for ENTYVIO IV for the same pediatric indication and plans to submit applications in additional markets later this year. The following table outlines the key clinical trials supporting these submissions.

Clinical Context and Executive Commentary

UC and Crohn's disease are lifelong, relapsing, remitting, inflammatory diseases of the gastrointestinal tract. In approximately 25 percent of patients, inflammatory bowel disease (IBD) is diagnosed before age 20, and its prevalence among children and adolescents continues to rise globally. Children with IBD often develop more extensive disease compared to adults.

"A child or teen diagnosed today with UC or Crohn's disease has decades of medical treatment ahead and represents one of the most challenging to treat patient populations in pediatric gastroenterology," said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit. "There is a need for additional treatments that can achieve clinical remission. The efficacy and safety profile of ENTYVIO is well-established in adults with more than a dozen years of scientific study and clinical data."

ENTYVIO is currently approved for the treatment of moderately to severely active UC and Crohn's disease in adults. It is a biologic therapy that specifically binds to the α4β7 integrin and blocks its interaction with MAdCAM-1, which is mainly expressed on gut endothelial cells. Marketing authorization has been granted in more than 80 countries for ENTYVIO IV and in more than 50 countries for ENTYVIO SC.