An announcement on December 18 revealed that Takeda has achieved positive topline results from two pivotal Phase 3 studies involving zasocitinib (TAK-279), a treatment for adults with moderate-to-severe plaque psoriasis. The studies demonstrated that zasocitinib, a selective oral tyrosine kinase 2 (TYK2) inhibitor, significantly outperformed placebo in key measures of efficacy, specifically the static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI) scores.
To discuss these findings, HCPLive spoke with Melinda Gooderham, MD, a dermatologist and medical director of the SKiN Centre for Dermatology in Ontario, Canada. Gooderham explained that the studies, referred to as the Latitude studies, were randomized, multicenter, double-blind, and included both placebo and active comparator controls. Conducted across 21 countries, the studies recruited 693 and 1,108 participants, respectively.
The co-primary endpoints were defined as the proportion of patients achieving an sPGA score of 0 or 1 and a PASI 75 response at the 16-week mark. Gooderham noted that there was a significant increase in PASI 75 responses as early as four weeks into treatment, with improvements continuing through to week 24.
Study Outcomes and Safety Profile
Takeda’s press release highlighted that all 44 ranked secondary endpoints were met, including sPGA 0, PASI 90, and PASI 100, when compared to both placebo and apremilast, another psoriasis treatment. Overall, the results indicated that zasocitinib was superior to placebo in achieving the co-primary endpoints.
In terms of safety, the drug was generally well-tolerated, with adverse events (AEs) consistent with earlier research. The most commonly reported AEs included upper respiratory tract infections, acne, and nasopharyngitis. Notably, no new safety signals were identified during the studies.
Gooderham emphasized the significance of a once-daily oral therapy that can provide complete skin clearance for those affected by psoriasis. “I think what’s exciting is that we’re seeing these levels of biologic efficacy,” she stated. “In the past, there has been a bit of a trade-off with our oral therapies being a little less effective than the biologics.”
Takeda plans to submit a New Drug Application to the US Food and Drug Administration (FDA) and other regulatory bodies in 2026. The data from these studies are also expected to be presented at upcoming medical congresses, further contributing to the understanding of this promising treatment.
Gooderham has reported nonfinancial support from Takeda, alongside personal fees from various pharmaceutical companies including AbbVie, Amgen, and Novartis. The collaborative nature of these findings underscores the ongoing efforts to enhance treatment options for individuals living with psoriasis.
