Takeda details 36.5% complete clearance versus Sotyktu in Phase 3

Complete skin clearance was more than twice as common on zasocitinib as on a marketed oral rival, as Takeda Pharmaceutical Company Limited TYO4502 NYSETAK released detailed Phase 3 psoriasis results on Wednesday. At week 16, 36.5 per cent of the zasocitinib arm achieved PASI 100, compared with 13.9 per cent on deucravacitinib.

Takeda said on June 11 that its LATITUDE Atlas study had met its primary and key secondary endpoints. Wednesday's release reports results for 301 patients on zasocitinib and 303 on deucravacitinib; the June topline said 606 people enrolled. The FDA has since accepted Takeda's psoriasis application for priority review, with a target action in the first quarter of 2027.

Takeda is a large Japanese drugmaker developing medicines across inflammation, oncology and rare diseases for global markets.

Takeda's U.S. shares NYSETAK closed Tuesday at US$18.51 in New York at 4:00:05 p.m. EDT. That close preceded Wednesday's data release and cannot show the market's response to the exact Atlas rates.

Atlas Reports Higher Clearance at Week 16

Atlas compared two once-daily oral treatments for adults with moderate-to-severe plaque psoriasis. Its primary endpoint was the PASI 100 response rate at week 16, a measure of complete skin clearance. In Takeda's Sept. 30 release, the difference between the arms carried a p value below 0.001.

At week 16, 62.5 per cent of zasocitinib patients achieved at least 90 per cent improvement on the Psoriasis Area and Severity Index, compared with 34.0 per cent on deucravacitinib. A physician assessment rated skin fully clear in 43.2 per cent versus 18.5 per cent. Takeda reported p values below 0.001 for both comparisons.

Takeda said zasocitinib was generally well tolerated in Atlas, with no new safety signals identified. Across its Phase 3 psoriasis trials, it listed upper respiratory tract infection, nasopharyngitis and acne as the most common adverse events.

Separate long-term findings came from LATITUDE PsO 3001 and 3002. In a post-hoc analysis of PsO 3001, Takeda said up to 93 per cent of patients who had responded at week 24 maintained skin clearance through week 52. That rate applies to prior responders and is distinct from the full Atlas groups' week 16 comparison.

In PsO 3002, a greater proportion of patients taking zasocitinib reached Dermatology Life Quality Index 0/1 at week four than those taking placebo or apremilast. Takeda said this threshold indicates that psoriasis had no effect on patients' quality of life. The result came from a separate study, so it is not another comparison with deucravacitinib.

"Across our Phase 3 trials, zasocitinib demonstrated superiority versus two distinct oral therapeutic classes in addition to rapid, durable and consistent skin clearance across patient types and in high-impact, hard-to-treat areas." Takeda senior vice-president Chinwe Ukomadu said in the Sept. 30 release.

Takeda Identified Three Studies in Its FDA Package

In its Sept. 14 announcement, Takeda identified PsO 3001 and 3002 as pivotal evidence for its new drug application, with an open-label PsO 3003 study providing support. The company described the pivotal trials as randomized, double-blind studies with placebo and active comparators. Takeda said the application had no significant impact on its fiscal-year forecast ending March 31, 2027.

The direct commercial rival is Bristol Myers Squibb NYSEBMY. Its Sept. 9, 2022 approval release says Sotyktu, the brand name for deucravacitinib, is approved in the United States for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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The FDA's target action falls in the first quarter of 2027. Its decision will determine whether Takeda may market zasocitinib for adults with moderate-to-severe plaque psoriasis in the United States.