Takeda Pharmaceuticals announced on December 18, 2023, positive topline results from two pivotal phase 3 studies evaluating the efficacy of zasocitinib (TAK-279) in adults suffering from moderate-to-severe plaque psoriasis. The studies demonstrated that the oral tyrosine kinase 2 (TYK2) inhibitor was superior to placebo in achieving the co-primary endpoints, which included the static Physician Global Assessment (sPGA) of 0/1 and a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) scores.
To gain insight into the findings, HCPLive spoke with Melinda Gooderham, MD, a dermatologist and medical director at the SKiN Centre for Dermatology in Ontario, Canada. Gooderham explained that the studies, referred to as the Latitude studies, were randomized, multicenter, double-blind trials that included both placebo and active comparator controls. Conducted across 21 countries, these studies involved a total of 1,801 participants, with 693 in one study and 1,108 in the other.
The co-primary endpoints were assessed at the 16-week mark, focusing on the proportion of patients achieving an sPGA score of 0 or 1 and those reaching a PASI 75 response compared to the placebo group. Gooderham highlighted that the studies showed a significantly greater number of PASI 75 responses as early as four weeks into treatment, with results improving further by Week 24. Takeda reported that all 44 ranked secondary endpoints were met, including sPGA 0, PASI 90, and PASI 100, when compared to both placebo and apremilast.
The safety profile of zasocitinib was consistent with previous research, and the drug was generally well tolerated among participants. The most frequently reported adverse events included upper respiratory tract infections, acne, and nasopharyngitis, with no new safety signals identified. Gooderham emphasized the significance of a once-daily oral treatment that could potentially offer complete skin clearance for individuals living with psoriasis. “The exciting aspect is that we’re seeing levels of biologic efficacy that have traditionally been a trade-off with oral therapies,” she noted.
In the announcement, Takeda indicated plans to present the full data at upcoming medical congresses. Furthermore, the company intends to submit a New Drug Application to the US Food and Drug Administration (FDA) and other regulatory authorities in 2026.
Gooderham has disclosed receiving nonfinancial support from Takeda, along with personal fees from several other pharmaceutical companies including AbbVie, Amgen, and Bristol Myers Squibb. These disclosures underscore the collaborative nature of clinical research and the ongoing efforts to improve treatment options for patients with psoriasis.
