Takeda’s Zasocitinib Shines in Phase 3 Psoriasis Trials

Takeda Pharmaceuticals announced on December 18, 2023, positive topline results from two pivotal Phase 3 studies examining the efficacy of zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis. The data revealed that the drug, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, showed significant superiority over placebo in achieving the co-primary endpoints: patients’ static Physician Global Assessment (sPGA) 0/1 and the Psoriasis Area and Severity Index (PASI) 75 scores.

To delve deeper into these findings, HCPLive spoke with Dr. Melinda Gooderham, a dermatologist and medical director of the SKiN Centre for Dermatology in Ontario, Canada. She described the studies as closely related, stating, “They’re the two duplicate, sister studies looking at zasocitinib, which is a highly selective TYK2 inhibitor, with both placebo and active comparator-controlled.”

Study Design and Key Findings

The Latitude studies comprised two randomized, multicenter, double-blind trials conducted across 21 countries. They enrolled 693 and 1,108 participants, respectively. The co-primary endpoints were the proportion of patients achieving sPGA 0/1 and PASI 75 response compared to placebo at the 16-week mark. Dr. Gooderham highlighted that the studies demonstrated a superior performance of zasocitinib versus placebo for these endpoints.

Significantly, the trials recorded a higher number of PASI 75 responses 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, when compared to both placebo and apremilast.

Safety and Future Plans

Zasocitinib was generally well tolerated among participants, with safety findings aligning with previous research. Dr. Gooderham emphasized the potential impact of a once-daily oral medication capable of achieving complete skin clearance for individuals affected by psoriasis. “I think what’s exciting is that we’re seeing these levels of biologic efficacy,” she remarked, noting that oral therapies have historically been less effective than biologics.

The most commonly reported adverse events up to the 24-week mark included upper respiratory tract infections, acne, and nasopharyngitis. Importantly, no new safety signals were identified during the studies.

Looking ahead, Takeda plans to present these findings at upcoming medical congresses and intends to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) and other regulatory authorities in 2026.

In addition to her role in these studies, Dr. Gooderham has disclosed nonfinancial support from Takeda and personal fees from various pharmaceutical companies, including AbbVie, Amgen, and Novartis, among others.

As the landscape of psoriasis treatment evolves, these promising results for zasocitinib may pave the way for new therapeutic options for patients seeking effective management of their condition.