Takeda Pharmaceutical Company Limited (NYSE:TAK) on Thursday shared topline results for the Phase 3 comparing zasocitinib (TAK-279) to Bristol-Myers Squibb Co.’s (NYSE:BMY) Sotyktu (deucravacitinib) in adults with moderate-to-severe plaque psoriasis (PsO).
Head-To-Head Trial Meets Endpoints
In the LATITUDE Atlas head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, Psoriasis Area and Severity Index (PASI) 100 response rate at week 16.
The study also demonstrated statistical superiority over deucravacitinib for all key secondary endpoints, including PASI 90 response and Static Physician’s Global Assessment (sPGA) 0 at week 16.
Zasocitinib was generally well tolerated with a consistent safety and tolerability profile and no new safety signals identified.
Investigators Highlight Skin Clearance Results
“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, 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.”
“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 Chinwe Ukomadu, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda.
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, Reuters reported.
Takeda said last year that, if approved, zasocitinib could achieve peak annual sales of $3 billion to $6 billion.
Next Steps For Zasocitinib Program
Takeda intends to present detailed data from the head-to-head study at upcoming medical congresses, building on landmark Phase 3 LATITUDE PsO results recently presented at the American Academy of Dermatology Annual Meeting.
The company is on track to submit a New Drug Application for plaque psoriasis with the U.S. Food and Drug Administration and other regulatory authorities starting this fiscal year.
TAK Price Action: Takeda Pharmaceutical Co shares were up 0.61% at $15.77 at the time of publication on Thursday, according to Benzinga Pro data.
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