Takeda Pharmaceuticals announced on December 18, 2023, promising topline results from two pivotal phase 3 studies on its investigational drug, zasocitinib (TAK-279), for treating adults with moderate-to-severe plaque psoriasis. The studies demonstrated that zasocitinib, a highly selective oral tyrosine kinase 2 (TYK2) inhibitor, significantly outperformed placebo in achieving the co-primary endpoints of static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 scores.
To discuss these findings, HCPLive spoke with Melinda Gooderham, MD, a dermatologist and medical director at the SKiN Centre for Dermatology in Ontario, Canada. “These are two duplicate, sister studies evaluating zasocitinib, which is a highly selective TYK2 inhibitor, with both placebo and active comparator controls,” Gooderham explained.
Study Details and Findings
The studies, referred to as the Latitude studies, were randomized, multicenter, double-blind, and involved both placebo and active comparator groups. Conducted across 21 countries, they enrolled 693 and 1,108 participants, respectively. The co-primary endpoints focused on the proportion of patients achieving sPGA 0/1 and PASI 75 response at the 16-week mark.
Gooderham emphasized the significance of the results, noting that zasocitinib demonstrated clear superiority over placebo for these endpoints. Notably, the studies revealed that PASI 75 responses were observed as early as the 4-week mark, with improvements continuing through to Week 24. Takeda’s announcement indicated that all 44 ranked secondary endpoints were met, including sPGA 0, PASI 90, and PASI 100, against both placebo and the active comparator, apremilast.
The drug was generally well tolerated, with safety findings aligning with previous research. Gooderham remarked on the importance of a once-daily oral treatment option that can deliver complete skin clearance for individuals living with psoriasis. “What’s exciting is that we are witnessing levels of biologic efficacy,” she stated. “In the past, there has been a trade-off with our oral therapies being less effective than biologics.”
Safety Profile and Future Plans
According to Takeda’s release, the most commonly reported adverse events (AEs) during the 24-week study period included upper respiratory tract infections, acne, and nasopharyngitis. Importantly, no new safety signals were identified by investigators during the trials.
As noted in a prior HCPLive release, these promising data are set to be presented at upcoming medical congresses. Additionally, Takeda plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) and other regulatory authorities in 2026.
Gooderham has disclosed receiving nonfinancial support from Takeda as well as personal fees from various pharmaceutical companies including AbbVie and Amgen. The insights shared in this summary were edited for clarity.
This advancement in psoriasis treatment could offer new hope for patients seeking effective management of their condition, marking a significant step forward in psoriasis care.
