Takeda eyes an FDA run for its investigational psoriasis pill after the drug elicited total skin clearance in more than 35% of patients at 16 weeks—more than 2.5 times that in controls taking Bristol Myers Squibb’s Sotyktu.
Takeda’s investigational oral psoriasis drug significantly outperformed Bristol Myers Squibb’s Sotyktu at achieving complete skin clearance in a Phase 3 psoriasis study, setting the Japanese pharma up for a regulatory filing in the coming months.
Treatment with Takeda’s daily pill zasocitinib resulted in complete skin clearance in over 35% of treated patients at 16 weeks, the company said in a Thursday release. This effect was “more than 2.5 times the response rate for [BMS’ Sotyktu],” Chinwe Ukomadu, head of the Gastrointestinal & Inflammation Therapeutic Area at Takeda, said in a prepared statement. Zasocitinib’s separation of efficacy from Sotkytu was evident as early as week 8, Ukomadu added.
Zasocitinib also beat out Sotyktu in terms of key secondary outcomes, including PASI 90 response, which refers to at least a 90% improvement in skin lesions.
“These findings reinforce the promise of zasocitinib to deliver rapid and durable skin clearance in a convenient once-daily pill,” Ukomadu said.
Takeda bought zasocitinib from Nimbus Therapeutics in December for $4 billion, beating out “almost every biopharmaceutical company,” Andy Plump, Takeda’s head of R&D, told Fierce Biotech in January 2024. The drug, designed with AI, works by targeting the TYK2 protein and maintaining IL-23 inhibition for 24 hours, which gives it its therapeutic potential for inflammatory conditions.
In December last year, Takeda said that “on average about 30 percent” of patients treated with zasocitinib across two late-stage studies achieved completely clear skin, while more than half reached PASI 90.
These findings “de-risk regulatory approval,” according to a Dec. 19 note from Jefferies, which forecasted at the time that the oral psoriasis market could top $5 billion by 2030. The data, the firm added, “validate Zasocitinib’s potential to redefine the oral psoriasis market.”
Takeda provided more data from two studies of zasocitinib in March, touting total skin clearance rates ranging from 25.2% to 33.4% at week 16. These figures were significantly better than in comparators on placebo or Amgen’s Otezla.
With Thursday’s head-to-head outcomes, Takeda said that it is on track to file a drug application for zasocitinib with the FDA and other global health authorities “starting this fiscal year.” The pharma’s fiscal year runs from April 1 through March 31 the following calendar year.
