Takeda zasocitinib beats deucravacitinib in Phase 3 psoriasis trial
Takeda Pharmaceutical (NYSE:TAK) reported positive topline results from a head-to-head Phase 3 clinical trial for its experimental plaque psoriasis drug, zasocitinib, positioning the oral pill to challenge established autoimmune blockbusters.
The Osaka, Japan-based drugmaker confirmed that zasocitinib met its primary endpoint in the LATITUDE Atlas trial, demonstrating clear statistical superiority over deucravacitinib, which is marketed by Bristol Myers Squibb under the brand name Sotyktu.
The success sets the stage for a highly competitive market battle within the next-generation class of oral medications designed to block the tyrosine kinase 2 (TYK2) enzyme, a primary pathway responsible for the chronic inflammation that triggers severe skin plaques.
The Phase 3 trial evaluated adults suffering from moderate-to-severe plaque psoriasis over a 16-week timeline.
According to the headline findings, more than 35% of the patients treated with once-daily zasocitinib achieved complete skin clearance, a metric known as a Psoriasis Area and Severity Index (PASI) 100 response rate.
That outcome represents more than 2.5 times the clearance rate achieved by the comparative cohort treated with deucravacitinib.
Researchers also observed a rapid onset of action, with the statistical efficacy curves of the two drugs separating as early as the eighth week of administration.
Beyond the primary metrics, Takeda's candidate achieved statistical superiority across all key secondary trial endpoints.
These included a significant margin of victory in PASI 90 response rates—indicating a 90% reduction in skin plaque severity—and higher percentages of patients scoring a zero on the Static Physician's Global Assessment scale, which signifies totally clear skin as determined by independent clinical evaluation.
From a safety standpoint, the oral pill was generally well-tolerated among the trial participants.
The tolerability and safety data matched previous clinical assessments from earlier testing phases, with no new safety signals or serious adverse events identified by the independent monitoring board.
Takeda plans to showcase the detailed data sets from the LATITUDE Atlas study at upcoming global medical congresses, expanding on standard Phase 3 data presented at the American Academy of Dermatology Annual Meeting.
The company confirmed that it remains on track to begin submitting its formal New Drug Application for plaque psoriasis to the U.S. Food and Drug Administration and other global health regulators within the current fiscal year.
If approved, zasocitinib will provide a highly potent oral alternative to standard injectable biologic treatments, shifting the competitive dynamics of a multi-billion-dollar global psoriasis market that has historically relied on subcutaneous injections to achieve total skin clearance.
