Takeda Pharmaceuticals announced significant findings on December 18, 2023, 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 demonstrated a clear advantage over placebo, achieving its co-primary endpoints of the static Physician Global Assessment (sPGA) 0/1 and the Psoriasis Area and Severity Index (PASI) 75 scores.
In an interview with HCPLive, Melinda Gooderham, MD, a dermatologist and medical director at the SKiN Centre for Dermatology in Ontario, Canada, elaborated on the studies. “They’re the two duplicate, sister studies looking at zasocitinib, which is a highly selective TYK-2 inhibitor, with both placebo and active comparator-controlled,” she stated.
The Latitude studies, designed as randomized, multicenter, double-blind trials, were conducted across 21 countries and involved a total of 1,801 participants (693 in one study and 1,108 in the other). The co-primary endpoints focused on the percentage of patients achieving sPGA 0/1 and PASI 75 responses compared to the placebo at the 16-week mark. Gooderham highlighted that the results demonstrated a significantly higher number of PASI 75 responses emerging as early as the 4-week mark, with improvements continuing through Week 24.
Takeda’s announcement emphasized that all 44 ranked secondary endpoints were met. These included sPGA 0, PASI 90, and PASI 100, evaluated against both the placebo and apremilast. Gooderham described the findings as a breakthrough, signifying a new level of biologic efficacy. “In the past, there has been a trade-off with our oral therapies being a little less effective than the biologics,” she noted.
Safety assessments indicated that the drug was generally well-tolerated, with adverse events consistent with previous research. The most common adverse effects reported through the 24-week mark included upper respiratory tract infections, acne, and nasopharyngitis. Notably, no new safety signals were identified during the studies.
These findings are expected to be presented at upcoming medical congresses, highlighting Takeda’s commitment to advancing treatments for psoriasis. Furthermore, the company plans to submit a New Drug Application to the US Food and Drug Administration (FDA) and other regulatory bodies in 2026.
Dr. Gooderham’s involvement in the studies and her professional insights underline the collaborative nature of this research. It is worth noting that she has received non-financial support from Takeda, alongside personal fees from numerous pharmaceutical companies, including AbbVie, Amgen, and others.
The promising results from these studies suggest that zasocitinib may provide a valuable new option for individuals living with psoriasis, potentially offering improved quality of life for many patients.
