Takeda has unveiled more data from its phase 3 trials of zasocitinib, demonstrating that the once-daily pill was able to clear or almost clear scalp psoriasis in 75% of patients.
The secondary endpoint findings come from a pair of late-stage studies that enrolled a combined 1,801 patients with moderate-to-severe plaque psoriasis. The Japanese pharma already disclosed last year that more than 50% of patients had a 90% improvement on the PASI scale and that about 30% of participants had clear skin.
Now, the company has used the American Academy of Dermatology Innovation Academy in New York to drill down into the TYK2 inhibitor's potential to treat high-impact and difficult-to-treat sites such as the scalp, palms, soles of the feet and nails. When it came to scalp psoriasis, 77% and 74% of patients in the two trials, respectively, saw their condition clear or almost clear at Week 16, compared with 7% and 13% of patients who received placebo, and 42% and 30% of patients on Amgen's psoriasis blockbuster Otezla.
For psoriasis of the palms and soles, this figure was nearly 70% according to Takeda, compared with 22% and 10% in the placebo groups and 44% and 43% in the Otezla cohorts in each trial.
“We ran two large pivotal studies, and got what I think was top-notch data showing that the drug works rapidly and is durable, and can lead to clear skin in a high percentage of people,” Chinwe Ukomadu, M.D., Ph.D., head of Takeda’s gastrointestinal and inflammation therapeutic area unit, told Fierce in an interview.
“Patients continue to tell us that they want convenient, rapid-acting drugs with durable response, capable of achieving clear skin,” Ukomadu said. “People who have psoriasis want the plaques gone.”
Takeda is no stranger to head-to-head comparisons. As well as testing zasocitinib against Otezla, the pharma proved its worth against Bristol Myers Squibb’s own TYK2 inhibitor, Sotyktu, in June via a separate study. Although both zasocitinib and Sotyktu act by inhibiting important cytokines involved in inflammation, the way the drugs bind to the tyrosine kinase 2 enzyme differs slightly. The mechanism of action of zasocitinib allows for 24-hour binding and inhibition of IL23 and other disease-driving immune pathways.
Takeda acquired zasocitinib from Nimbus Therapeutics for $4 billion upfront in 2022, and the Tokyo-based company has forecast peak potential revenue of $3 billion to $6 billion in psoriasis and psoriatic arthritis, reflecting a belief that the candidate is as good or better than any other oral drug that is approved or coming to market in the near future.
“The scientific hypothesis I heard when we brought the drug in is living up to its merit—we think it's a good drug scientifically,” Ukomadu told Fierce. “I am not surprised that we are translating biochemical findings of this drug into clinical findings in patients who have the disease.”
Takeda plans to submit zasocitinib for FDA approval before the end of its financial year, Ukomadu confirmed.
Takeda’s pipeline also includes drugs to treat other dermatologic diseases, such as vitiligo and hidradenitis suppurativa, as well as gastrointestinal diseases, including Crohn’s disease and ulcerative colitis. Meanwhile, a phase 3 study is ongoing for zasocitinib in psoriatic arthritis.
“We really feel confident that zasocitinib does have the potential to be a once daily, rapid, durable drug that patients can take that has the potential to lead to clear skin,” he added.