Takeda Pharmaceutical Company announced on December 18, 2023, promising topline results from two pivotal Phase 3 studies evaluating zasocitinib (TAK-279) for adults suffering from moderate-to-severe plaque psoriasis. This next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor showed significant superiority over placebo in achieving co-primary endpoints: patients’ static Physician Global Assessment (sPGA) scores of 0/1 and a Psoriasis Area and Severity Index (PASI) 75 response.
To delve into the findings, HCPLive spoke with Melinda Gooderham, MD, a dermatologist and medical director at the SKiN Centre for Dermatology located in Ontario, Canada. “These are two duplicate, sister studies looking at zasocitinib, which is a highly selective TYK-2 inhibitor, both placebo-controlled and active comparator-controlled,” Gooderham explained.
Study Design and Key Findings
The studies, referred to as the Latitude studies, were randomized, multicenter, double-blind, and involved 693 and 1,108 participants across 21 countries. The co-primary endpoints measured the proportion of patients achieving sPGA 0/1 and PASI 75 responses at the 16-week mark. Gooderham highlighted that results showed a significantly greater number of PASI 75 responses as early as four weeks into treatment, with improvements continuing through Week 24.
Takeda’s announcement indicated that all 44 ranked secondary endpoints were met, including sPGA 0, PASI 90, and PASI 100, when compared to both placebo and apremilast. The drug was generally well tolerated, with safety findings aligning with previous research data. Gooderham praised the potential of a once-daily oral agent to provide complete skin clearance for those affected by psoriasis. “What’s exciting is that we’re seeing these levels of biologic efficacy,” she noted. “In the past, there has been a trade-off with our oral therapies being less effective than biologics.”
Safety and Future Outlook
In terms of safety, the most commonly reported adverse events up to the 24-week mark included upper respiratory tract infections, acne, and nasopharyngitis. Notably, no new safety signals were identified by the researchers. These findings are set to be presented at upcoming medical congresses, as mentioned in a previous HCPLive release.
Looking ahead, Takeda plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) and other regulatory authorities in 2026. Gooderham, who has received nonfinancial support from Takeda, also disclosed personal fees from various pharmaceutical companies, including AbbVie, Amgen, and Pfizer, among others.
The results from these studies mark a significant advancement in the treatment landscape for psoriasis, offering hope for improved patient outcomes with a new oral therapy option.
