Psoriasis Treatment Breakthrough
Takeda's AI-Developed Zasocitinib Shows Superior Efficacy Against Sotyktu in Psoriasis Trial
Key Points
In the Phase 3 LATITUDE Atlas trial, 606 participants were randomized to zasocitinib 30 mg once daily versus deucravacitinib (Sotyktu) 6 mg once daily for 16 weeks.
Takeda said the drug was developed using AI—framed as a broader industry shift intended to “speed drug development,” “shorten clinical trial timelines” and “reduce animal testing.”
Takeda’s acquisition of zasocitinib from Nimbus Therapeutics in 2022 was described as a deal valued at up to $6 billion.
Henry Ford Health dermatologist and LATITUDE Atlas principal investigator Linda Stein Gold, M.D., said the head-to-head results “clearly demonstrated superior skin clearance” and highlighted “clinically meaningful differences within the oral treatment class,” adding that the findings “support the potential of zasocitinib to help transform what patients and physicians can expect from an oral option.”
The LATITUDE Atlas readout adds to earlier LATITUDE Phase 3 work comparing zasocitinib with placebo and the active comparator apremilast; those trials reported co-primary endpoints including sPGA 0/1 and PASI 75 at week 16, and Dermatology Times reported durability out to week 60 with more than 90% maintaining results.
Takeda's once-daily pill zasocitinib cleared skin completely in about 35% of psoriasis patients — more than twice the rate of Bristol Myers Squibb's Sotyktu — in a direct head-to-head Phase 3 trial. BioSpace reported the drug, developed using AI, hit its primary goal of statistical superiority and could reshape what patients expect from an oral treatment.
The 16-week LATITUDE Atlas study enrolled 606 adults with moderate-to-severe plaque psoriasis. Patients on zasocitinib 30 mg once daily achieved complete clearance — a score called PASI 100 — at roughly 35% versus about 14% on Sotyktu. The gap between the two drugs appeared as early as week 8.
Head-to-Head Numbers Show a Clear Winner
PASI 100 means zero visible psoriasis. Zasocitinib hit that bar in more than one-in-three patients. Sotyktu managed it in roughly one-in-seven. Zasocitinib also beat Sotyktu on PASI 90 — nearly clear skin — and on sPGA 0, a separate doctor-rated scale, both listed as key secondary goals. Benzinga confirmed statistical superiority on all those measures.
Takeda said no new safety signals appeared and that the tolerability profile matched earlier studies. Dr. Linda Stein Gold, a Henry Ford Health dermatologist and the study's principal investigator, said the results "clearly demonstrated superior skin clearance" and highlighted "clinically meaningful differences within the oral treatment class." She added the data "support the potential of zasocitinib to help transform what patients and physicians can expect from an oral option."
AI-Designed Molecule Acquired for Up to $6 Billion
Zasocitinib was not discovered in a traditional lab. Nimbus Therapeutics used AI-driven computational chemistry to design the molecule, targeting the TYK2 enzyme with high selectivity. Takeda bought it from Nimbus in December 2022 for $4 billion upfront, with up to $2 billion more in milestone payments — a total deal of up to $6 billion, according to Reuters.
Takeda has framed AI development as a tool to "speed drug development," "shorten clinical trial timelines," and "reduce animal testing." The LATITUDE Atlas result gives that narrative a major data point. The higher selectivity for TYK2 — compared to older JAK inhibitors, which carry serious safety warnings — is what allowed Takeda to dose higher and chase biologic-level clearance in a pill.
Sotyktu Faces Market Pressure as BMS Defends Its Lead
BMS launched Sotyktu in 2022 as the world's first approved TYK2 inhibitor. It built a safety track record and reached roughly $1.1 billion in annual revenue. Now that data shows zasocitinib achieving a 2-to-1 edge in complete clearance, analysts at Jefferies and J.P. Morgan — as noted by Reuters — say payers will find the gap "impossible to ignore" when setting formulary coverage.
BMS has previously leaned on its first-mover advantage and established safety database. It has not issued a formal rebuttal to the LATITUDE Atlas data. Takeda's shares rose on the Tokyo Stock Exchange following the announcement. Detailed trial results are expected to be presented at a future medical conference, according to Guru Focus.
Takeda Bets on Blockbuster Sales to Replace Entyvio Revenue
Takeda's top-selling drug, Entyvio, faces a patent cliff. The company has openly positioned zasocitinib as its planned replacement. If the FDA approves it — a decision Takeda expects this fiscal year — projected peak annual sales run from $3 billion to $6 billion, according to Reuters. That would make it one of the biggest launches in dermatology history.
Durability data from earlier LATITUDE Phase 3 studies adds to the case. Dermatology Times reported that more than 90% of responders maintained their results out to week 60. Takeda is also running trials in psoriatic arthritis, Crohn's disease, and ulcerative colitis — aiming to build a multi-disease franchise similar to older biologics like adalimumab.
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