Takeda’s oral tyrosine kinase 2 (TYK2) inhibitor has outperformed Bristol Myers Squibb’s (BMS) Sotyktu (deucravacitinib) in adults with moderate-to-severe plaque psoriasis (PsO).
In the Phase III LATITUDE Atlas head-to-head study (NCT06973291), Takeda’s zasocitinib demonstrated statistical superiority over Sotyktu in the Psoriasis Area and Severity Index (PASI) 100 response rate at week 16, the primary endpoint. More than 35% of zasocitinib patients achieved this endpoint, more than 2.5 times the response rate for Sotyktu.
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The study also demonstrated statistical superiority over Sotyktu 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.
Dr Linda Stein Gold, director of dermatology clinical research at Henry Ford Health and principal investigator for the LATITUDE Atlas study, said: “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.”
Based on this data, as well as other Phase III LATITUDE PsO data from the 3001 and 2003 trials (NCT06088043 and NCT06108544), Takeda is set to submit a New Drug Application (NDA) for plaque psoriasis with the US Food and Drug Administration (FDA) and other regulatory authorities starting this fiscal year.
In the Latitude PsO 3001 and 3002 studies, more than half of patients treated with zasocitinib achieved clear or almost clear skin at week 16, a key measure of treatment success. In the 3001 trial, 71.4% patients treated with zasocitinib achieved a sPGA score of 0/1 versus 10.7% of placebo patients and 32.1% of patients on Otezla (apremilast) after 16 weeks of treatment. As well as this, 61.3% of patients treated with zasocitinib achieved PASI 90 versus 5% of placebo patients and 16.8% of Otezla patients.
In the 3002 trial, 69.2% of patients treated with zasocitinib achieved a sPGA score of 0/1 versus 12.6% on placebo and 29.7% on Otezla. With PASI90, this was achieved by 51.9% of patients treated with zasocitinib compared with 4% on placebo and 15.9% on Otezla.
Amgen’s Otezla is PDE4 inhibitor approved for PsO treatment.
Psoriasis is a chronic, systemic immune-mediated inflammatory disease characterised by itchy, painful, disfiguring and disabling skin lesions that impact a person’s physical, emotional and psychological well-being.
Globally, an estimated 64 million people are living with psoriasis, and about 80%-90% of those have PsO.
Sotyktu and AbbVie’s Skyrizi (risankizumab) currently dominate the PsO market in the US. Sotyktu is an oral small molecule inhibitor that targets tyrosine kinase 2 (TYK2), while Skyrizi is AbbVie’s blockbuster injected monoclonal antibody (mAb) that inhibits IL-23.
Johnson & Johnson (J&J) is also set to make an impact on the PsO market, with its drug Icotyde (icotrokinra), having gained FDA approval in March 2026. J&J said that Icotyde is the first and only targeted oral peptide that precisely blocks the IL-23 receptor.
Icotyde will succeed J&J’s Stelara (ustekinumab), an IL-23 inhibitor approved for PsO treatment that lost patent exclusivity in early 2025. J&J also has Tremfya (guselkumab) on the market in this indication, though like Skyrizi, the drug is injected.
This comes as GlobalData predicts that PsO drug sales across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) will reach $11.56bn in 2030.
GlobalData is the parent company of Clinical Trials Arena.
