Takeda Reports Positive Phase 3 Results for Zasocitinib in Psoriasis

Takeda Pharmaceutical Company announced on December 18, 2023, promising topline findings from two pivotal phase 3 studies evaluating the efficacy of zasocitinib (TAK-279) in adults suffering from moderate-to-severe plaque psoriasis. This next-generation oral tyrosine kinase 2 (TYK2) inhibitor showed significant superiority over placebo in achieving the co-primary endpoints of the studies, specifically the static Physician Global Assessment (sPGA) 0/1 and the Psoriasis Area and Severity Index (PASI) 75 scores.

To discuss these findings, HCPLive interviewed Melinda Gooderham, MD, a dermatologist and the medical director of the SKiN Centre for Dermatology in Ontario, Canada. Dr. Gooderham described the studies as “two duplicate, sister studies” that were randomized, multicenter, double-blind, and controlled with both a placebo and an active comparator. Conducted in 21 countries, the studies enrolled 693 and 1,108 participants, respectively.

The primary outcomes were measured at the 16-week mark, focusing on the proportion of patients achieving sPGA 0/1 and PASI 75 responses compared to the placebo group. Dr. Gooderham noted that the results demonstrated a significantly higher number of PASI 75 responses as early as the four-week evaluation, with continued improvement noted through to the 24-week assessment.

Study Outcomes and Safety Profile

In Takeda’s announcement, all 44 ranked secondary endpoints were met, including sPGA 0, PASI 90, and PASI 100, against both placebo and apremilast. Dr. Gooderham emphasized the importance of a once-daily oral treatment that potentially offers complete skin clearance for patients living with psoriasis. She stated, “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.”

The drug’s safety profile appeared consistent with previous studies, with the most commonly reported adverse events (AEs) through the 24-week mark being upper respiratory tract infections, acne, and nasopharyngitis. Notably, no new safety signals were identified during the trials, which is an encouraging sign for potential users.

Future Developments and Regulatory Plans

Takeda plans to present these data 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. Dr. Gooderham has acknowledged receiving nonfinancial support from Takeda and personal fees from various pharmaceutical companies, including AbbVie, Amgen, and others, for transparency regarding potential conflicts of interest.

As the psoriasis treatment landscape evolves, the findings from these phase 3 studies suggest that zasocitinib may represent a significant advancement in the management of this chronic condition, offering hope for effective oral therapies that deliver robust results.