Takeda Pharmaceutical Company announced positive topline results from two pivotal Phase 3 studies on December 18, 2023. The studies focus on the efficacy of zasocitinib (TAK-279), an oral tyrosine kinase 2 (TYK2) inhibitor, in adults suffering from moderate-to-severe plaque psoriasis. The drug outperformed placebo in achieving the co-primary endpoints of the studies, namely the static Physician Global Assessment (sPGA) scores of 0/1 and a Psoriasis Area and Severity Index (PASI) 75 response.
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 significance of the findings. “These are the two duplicate, sister studies examining zasocitinib, which is a highly selective TYK-2 inhibitor,” she stated. The studies, known as the Latitude studies, were randomized, multicenter, and double-blind, involving both placebo and active comparator groups. They took place across 21 countries and included a total of 1,801 participants.
The studies aimed to determine the proportion of patients achieving sPGA 0/1 and PASI 75 responses at the 16-week mark. Gooderham noted that the results indicated a significantly greater number of PASI 75 responses as early as the four-week mark, continuing to improve through to Week 24. Takeda’s announcement highlighted that all 44 ranked secondary endpoints were met, including sPGA 0, PASI 90, and PASI 100 compared to both placebo and apremilast.
The safety profile of zasocitinib was consistent with previous studies, and the drug was generally well tolerated by participants. Gooderham expressed enthusiasm about the potential of a once-daily oral treatment that could provide complete skin clearance for psoriasis patients. “What’s exciting is that we’re seeing these levels of biologic efficacy,” she remarked. “Previously, oral therapies had a trade-off of being less effective than biologics.”
The most commonly observed adverse events through the 24-week period included upper respiratory tract infections, acne, and nasopharyngitis. Investigators reported no new safety signals emerging from the data. Takeda plans to present these findings at upcoming medical congresses and intends to submit a New Drug Application to the US Food and Drug Administration (FDA) along with other regulatory authorities in 2026.
Gooderham has disclosed nonfinancial support from Takeda, in addition to receiving personal fees from various pharmaceutical companies including AbbVie, Amgen, and Novartis, among others.
These promising results may pave the way for improved treatment options for individuals living with psoriasis, emphasizing the potential of zasocitinib as a significant advancement in the management of this chronic skin condition.
