Takeda has won the TYK2 inhibitor battle, defeating Bristol-Myers Squibb’s Sotiktu, and strengthening its position ahead of an expected launch for plaque psoriasis next year.
The Phase 3 trial compared BMS’s Sotiktu with zasotitinib, a TYK2 inhibitor that Takeda acquired in 2022 for an upfront payment of $4 billion. In a cross-study comparison, up to 33.4% of patients with moderate to severe plaque psoriasis had clear skin after treatment in Takeda’s earlier Phase 3 trial, compared with up to 14% of Sotiktu’s patients, suggesting that zasocitinib easily wins the battle.
On Thursday, Professor Takeda shared data showing that cross-examination comparisons held up for head-to-head exams. Takeda reported a PASI 100 indicating complete skin clearance in “more than 35%” of patients receiving zasocitinib at week 16. The Japanese pharmaceutical company said this was “more than 2.5 times” the response rate of Sotiktu, and that it had met its primary endpoint.
Takeda has not yet released more detailed data from the trial, but has shared other findings. Zasocitinib outperformed Sotix on all key secondary endpoints, including skin clearance of 90% and proportion of patients with a score of zero on the Week 16 Static Physician Global Assessment. Zasocitinib demonstrated a consistent safety and tolerability profile, with no new safety signals and was generally well tolerated, Takeda said in a June 11 release.
The superiority of zasotitinib over sotiktu was evident from week 8. Takeda has identified early efficacy as a key outcome in psoriasis. Patients can see and feel the difference right away, which can impact their retention and satisfaction with their treatment, Andrew Plump, Takeda’s president of research and development, said during an earnings call in May.
In a previous trial, zasocitinib outperformed Amgen’s Otezla on PASI 90 starting at week 4.
New data could increase pressure on Sotiktou. In 2019, BMS opted to keep assets that were under investigation at the time and sell its blockbuster product Otezla in order to secure regulatory approval for its Celgene acquisition. The FDA approved Sotiktu in 2022, but sales, which BMS suggested could reach $4 billion, are slowly increasing. Sotyktu generated $291 million for BMS last year (PDF). This reflects a 5% decline in U.S. sales and growth internationally.
Ikotide, an IL-23 receptor antagonist from Johnson & Johnson and Protagonist Therapeutics, defeated Sotiktu for 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 expecting to file for FDA approval in the fourth quarter.
