Takeda Pharmaceuticals announced on December 18, 2023, promising topline results from two pivotal Phase 3 studies involving zasocitinib (TAK-279) for adults suffering from moderate-to-severe plaque psoriasis. The data indicated that the new oral medication demonstrated significant efficacy when compared to placebo, achieving key endpoints related to skin improvement.
Zasocitinib, a next-generation selective oral tyrosine kinase 2 (TYK2) inhibitor, was evaluated in two randomized, multicenter, double-blind studies referred to as the Latitude studies. According to Dr. Melinda Gooderham, a dermatologist and medical director at the SKiN Centre for Dermatology in Ontario, Canada, these studies involved the recruitment of 693 and 1108 participants across 21 countries. The co-primary endpoints focused on the percentage of patients achieving a static Physician Global Assessment (sPGA) score of 0 or 1 and a Psoriasis Area and Severity Index (PASI) 75 response at the 16-week mark.
The results were particularly notable, with significant improvements observed as early as the 4-week mark, continuing to rise through to Week 24. “The studies clearly demonstrated the superiority of zasocitinib compared to placebo for the co-primary endpoints,” Gooderham highlighted. She also pointed out that all 44 ranked secondary endpoints were met, which included sPGA 0, PASI 90, and PASI 100, showcasing its robust efficacy profile.
The safety profile of zasocitinib was consistent with earlier research, and the drug was generally well tolerated among participants. Common adverse events noted during the trials included upper respiratory tract infections, acne, and nasopharyngitis. Importantly, no new safety signals were identified by investigators throughout the duration of the studies.
Gooderham expressed optimism about the implications of a once-daily oral medication capable of achieving complete skin clearance for individuals living with psoriasis. “What’s exciting is that we’re seeing these levels of biologic efficacy. In the past, there has been a trade-off with oral therapies being less effective than biologics,” she stated.
Takeda plans to present these findings at upcoming medical congresses, with the intention of filing a New Drug Application with the U.S. Food and Drug Administration (FDA) and other regulatory agencies in 2026. This marks a significant step forward for both the company and patients seeking effective treatment options for psoriasis.
In summary, the recent Phase 3 data on zasocitinib presents a promising advancement in psoriasis management, potentially offering patients a highly effective oral treatment option, while also contributing to the ongoing evolution of therapeutic strategies in dermatology.
