Takeda Reports Promising Phase 3 Results for Zasocitinib in Psoriasis

Takeda Pharmaceutical Company announced on December 18, 2023, significant positive topline results from two pivotal Phase 3 studies evaluating the efficacy of zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis. This investigational drug, a selective oral tyrosine kinase 2 (TYK2) inhibitor, showed superior results compared to placebo, particularly in achieving the co-primary endpoints of the studies, namely the static Physician Global Assessment (sPGA) 0/1 and the Psoriasis Area and Severity Index (PASI) 75 scores.

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

The co-primary endpoints aimed to measure the proportion of patients achieving sPGA 0/1 and PASI 75 responses at the 16-week mark. Dr. Gooderham emphasized that the studies demonstrated the superiority of zasocitinib over placebo, noting that a significant number of PASI 75 responses were recorded as early as Week 4 and continued to improve through Week 24.

In Takeda’s announcement, it was highlighted that all 44 ranked secondary endpoints were met, including sPGA 0, PASI 90, and PASI 100 scores when compared to both placebo and apremilast. The findings indicate a robust therapeutic effect and suggest that zasocitinib may provide a new treatment option for individuals struggling with psoriasis.

The safety profile of zasocitinib appeared consistent with earlier research, and the drug was generally well tolerated by participants. Dr. Gooderham pointed out the significance of a once-daily oral medication that can potentially deliver complete skin clearance for psoriasis patients. She remarked, “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.”

According to Takeda, the most commonly reported adverse events (AEs) through the 24-week follow-up included upper respiratory tract infections, acne, and nasopharyngitis. Notably, investigators did not identify any new safety signals during the trials.

These promising data are expected to be presented at upcoming medical congresses, providing further opportunities for discussion within the medical community. Takeda also revealed plans to submit a New Drug Application to the US Food and Drug Administration (FDA) along with other regulatory authorities in 2026.

Dr. Gooderham has disclosed that she receives non-financial support from Takeda, alongside personal fees from several pharmaceutical companies, including AbbVie, Amgen, and Bristol Myers Squibb, among others. This transparency underscores the importance of maintaining integrity in reporting clinical findings.

As the landscape of psoriasis treatment continues to evolve, the results from these Phase 3 studies of zasocitinib represent a potentially significant advance in the management of this chronic skin condition, offering hope for improved patient outcomes.