Takeda Pharmaceutical Company announced positive findings from two pivotal Phase 3 studies on its oral medication, zasocitinib (TAK-279), aimed at treating adults with moderate-to-severe plaque psoriasis. Released on December 18, the topline results show that the drug significantly outperformed placebo in achieving the co-primary endpoints of the studies. Specifically, it demonstrated improvements in patients’ static Physician Global Assessment (sPGA) scores of 0/1 and a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) after 16 weeks of treatment.
To gain insights into 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 randomized, multicenter, double-blind trials that evaluated the efficacy of zasocitinib against both placebo and an active comparator. Conducted across 21 countries, the trials involved the recruitment of 693 and 1108 participants, respectively.
Key Findings and Efficacy
The studies focused on the proportion of patients who achieved an sPGA score of 0/1 and PASI 75 response at the 16-week mark. Dr. Gooderham noted that a significantly larger number of participants exhibited PASI 75 responses as early as 4 weeks into treatment, with results continuing to improve through to Week 24. The trials met all 44 ranked secondary endpoints, including achieving PASI 90 and PASI 100 compared to both placebo and apremilast.
In Takeda’s announcement, the overall safety profile of zasocitinib was described as consistent with previous studies. The drug was generally well tolerated, with the most common adverse events reported through the 24-week assessment being upper respiratory tract infections, acne, and nasopharyngitis. No new safety signals were identified by the investigators.
Dr. Gooderham emphasized the importance of a once-daily oral treatment that can provide complete skin clearance for individuals with psoriasis. She remarked, “I think 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.”
Regulatory Plans and Future Outlook
The data from these studies are expected to be presented at upcoming medical congresses, as indicated in a prior HCPLive release. Additionally, Takeda plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) and other regulatory authorities in 2026.
Dr. Gooderham has disclosed non-financial support from Takeda, alongside personal fees from various pharmaceutical companies, including AbbVie, Amgen, and Bristol Myers Squibb, among others. These disclosures highlight her extensive engagement within the dermatology field and the pharmaceutical industry.
As Takeda moves forward with these promising results, the potential for zasocitinib to become a pivotal treatment for psoriasis remains high, offering hope to those affected by this chronic skin condition.
