Takeda has won the battle of the TYK2 inhibitors, toppling Bristol Myers Squibb’s Sotyktu to strengthen its hand ahead of an anticipated plaque psoriasis launch next year.
The phase 3 trial compared the TYK2 inhibitor zasocitinib, which Takeda acquired for $4 billion upfront in 2022, to BMS' Sotyktu. Cross-trial comparisons suggested zasocitinib would easily win the fight, with up to 33.4% of moderate to severe plaque psoriasis patients in Takeda’s earlier phase 3 studies having clear skin after treatment versus up to 14% of patients on Sotyktu.
Thursday, Takeda shared data showing that the cross-trial comparison held up in the head-to-head study. At Week 16, Takeda reported PASI 100, indicating complete skin clearance, in “more than 35%” of patients on zasocitinib. The Japanese drugmaker described this as “more than 2.5 times” the response rate for Sotyktu, achieving its primary endpoint.
Takeda has yet to post more detailed data from the trial but has shared other findings. Zasocitinib beat Sotyktu on all key secondary endpoints, including the proportion of patients with 90% skin clearance and a zero score on the Static Physician's Global Assessment at Week 16. Zasocitinib was generally well tolerated with a consistent safety and tolerability profile and no new safety signals, Takeda said in a June 11 release.
Zasocitinib’s advantage over Sotyktu was evident from Week 8. Takeda has identified early efficacy as an important outcome in psoriasis. Patients can see and feel the difference quickly, and that can influence their persistence and satisfaction with therapy, Andrew Plump, president of R&D at Takeda, said on an earnings call in May.
In earlier trials, zasocitinib had a PASI 90 edge over Amgen’s Otezla from Week 4.
The new data may increase the pressure on Sotyktu. In 2019, BMS chose to keep the then-investigational asset and sell the blockbuster Otezla to secure regulatory clearance for its Celgene takeover. The FDA approved Sotyktu in 2022, but sales, which BMS tipped to hit $4 billion, have ramped slowly. Sotyktu generated (PDF) $291 million for BMS last year, reflecting a 5% drop in U.S. sales and growth overseas.
Johnson & Johnson and Protagonist Therapeutics’ IL-23 receptor antagonist, Icotyde, beat Sotyktu on its way to FDA approval in March.
Takeda aims to launch zasocitinib in the first half of 2027. Alumis’ TYK2 inhibitor is on a similar trajectory, with the biotech planning to file for FDA approval in the fourth quarter.