Takeda Pharmaceuticals has announced promising results from two pivotal Phase 3 studies on zasocitinib (TAK-279), an oral treatment for adults suffering from moderate-to-severe plaque psoriasis. On December 18, 2023, the company revealed that the studies met their co-primary endpoints, demonstrating the drug’s superiority over placebo. The findings are expected to have significant implications for patients seeking effective management options for this chronic skin condition.
To discuss these findings, HCPLive spoke with Melinda Gooderham, MD, a dermatologist and medical director at the SKiN Centre for Dermatology in Ontario, Canada. Gooderham detailed the design of the studies, which were randomized, multicenter, double-blind, and included both placebo and active comparator controls. Conducted across 21 countries, the studies enrolled a total of 1,801 participants; 693 in one study and 1,108 in the other.
The co-primary endpoints evaluated the proportion of patients achieving a static Physician Global Assessment (sPGA) score of 0 or 1, as well as a PASI 75 response after 16 weeks of treatment. Gooderham emphasized that the results clearly demonstrated the efficacy of zasocitinib, noting that patients began to show significant PASI 75 responses as early as the four-week mark, with improvements continuing through to the 24-week assessment.
In addition to the co-primary endpoints, all 44 ranked secondary endpoints were also met, including measures of complete skin clearance such as sPGA 0, PASI 90, and PASI 100, when compared to both placebo and apremilast. This comprehensive success indicates a robust performance for zasocitinib as a treatment option.
The safety profile of zasocitinib was consistent with previous studies, and it was generally well tolerated among participants. The most commonly reported adverse events included upper respiratory tract infections, acne, and nasopharyngitis. Notably, no new safety signals were identified during the trials.
Gooderham expressed her enthusiasm for the drug, highlighting its potential as a once-daily oral agent that may offer complete skin clearance for individuals living with psoriasis. She remarked, “I think what’s exciting is that we’re seeing these levels of biologic efficacy. In the past, there has been a bit of a trade-off with our oral therapies being a little less effective than the biologics.”
Looking ahead, Takeda plans to present these findings at upcoming medical congresses and is preparing to submit a New Drug Application to the United States Food and Drug Administration (FDA) and other regulatory agencies in 2026. These developments reflect Takeda’s commitment to advancing treatment options for patients suffering from psoriasis.
As the medical community anticipates further insights from these studies, the results may pave the way for more effective management strategies for individuals affected by this condition. The research underscores the importance of continuous innovation in pharmaceutical treatments, aiming to enhance patient outcomes in dermatology.
