Apremilast

Dive Brief:Takedas experimental autoimmune drug zasocitinib bested Bristol Myers Squibbs marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday. Takeda didnt provide detailed data, but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. Its the second time Takedas drug has beaten an approved therapy, following positive results in a trial testing it against Amgens Otezla.Zasocitinib is a newer kind of TYK2 inhibitor, a class of oral autoimmune medicines that have attracted significant industry investment in recent years. Its become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.Dive Insight:Sotyktu was the first TYK2 inhibitor to gain Food and Drug Administration approval.But it hasnt yet become the kind of seller Bristol Myers once hoped. The drug recorded $291 million in revenue in 2025 and, with an expected clearance coming in psoriatic arthritis, Bristol Myers recently revealed plans to no longer promote Sotyktu in dermatology in many markets.Polling by some analysts has suggested that many dermatologists prefer injectable biologics due to Sotyktus lower efficacy. Takeda, then, may have to convince doctors that zasocitinib is clearly better if it hopes to draw patients away from effective shots like AbbVies Skyrizi and J&Js Tremfya.The company, for its part, has been optimistic about zasocitinibs chances. On a May earnings call with analysts, CEO-elect Julie Kim claimed the drug is poised to be a leading oral treatment option with the potential to significantly expand the growing market for psoriasis pills.When you look at the market, oral treatments are already the fastest-growing segment, with the number of patients on advanced oral therapy expected to triple over the next decade, Kim told analysts.The study results disclosed Thursday could help Takedas case. In the head-to-head trial,zasocitinib helped 35% of the people who took it achieve a measure called PASI 100, a benchmark of complete skin clearance with no visible lesions. That figure was 2.5-times better than Sotyktu, a statistically significant difference that met the studys main goal. Takeda didnt state the exact number associated with Sotyktu, but in Bristol Myersclinical trials, up to 14% of trial enrollees hit the PASI 100 mark.Zasocitinib was also statistically better than Sotyktu on all secondary endpoints, which included partial skin clearance measures such as PASI 90 and PASI 75. The PASI 100 rate would fall short of whats been seen in testing of Skyriziand Tremfya, although zasocitinib hasnt been evaluated directly against those drugs.As expectations for oral therapies continue to rise, these findings support the potential of zasocitinib to help transform what patients and physicians can expect from an oral option in plaque psoriasis, said Linda Stein Gold, the director of dermatology clinical research at Henry Ford Health and a lead trial investigator, in a statement.An equally important trial readout is expected for zasocitinib in inflammatory bowel disease later this year. Two TYK2 drugs, including Sotyktu, have failed studiesin people with ulcerative colitis or Crohns disease. '

iStock, cyano66 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 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.