ClinicalTakeda’s Inhibitor Gets the Better of BMS’ Sotyktu in...

Takeda’s Inhibitor Gets the Better of BMS’ Sotyktu in Phase 3 Psoriasis Battle

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Takeda has outperformed Bristol Myers Squibb (BMS) in the competition among TYK2 inhibitors, edging out Sotyktu and strengthening its position ahead of an expected plaque psoriasis launch next year.

The phase 3 trial compared Takeda’s TYK2 inhibitor, zasocitinib – which the company acquired for $4 billion upfront four years ago – with BMS’ Sotyktu. Earlier cross-trial comparisons had indicated that zasocitinib could significantly outperform its rival, with over 33% of patients with moderate to severe plaque psoriasis achieving complete skin clearance in Takeda’s previous phase 3 studies, compared to as few as 14% of patients receiving Sotyktu.

Takeda released data confirming that those earlier expectations were borne out in the direct comparison study. By the 16th week, more than 35% of patients receiving zasocitinib achieved PASI 100, a measure indicating complete skin clearance. Takeda indicated that this response rate was more than 2.5 times higher than that seen with Sotyktu, allowing the study to meet its primary goal.

Although Takeda has not yet released full trial details, the company reported that zasocitinib outperformed Sotyktu across all key secondary endpoints, including the proportion of patients achieving 90% skin clearance and those reaching a zero score on the Static Physician’s Global Assessment at the 16th week. Takeda also reported that zasocitinib was mostly well tolerated, with a safety and tolerability profile consistent with previous findings and no newly identified safety concerns.

The superiority of zasocitinib over Sotyktu became apparent as early as the 8th week. Takeda has emphasized the importance of rapid symptom improvement in psoriasis treatment, with Andrew Plump, president of R&D at Takeda, explaining during a May earnings call that patients who experience visible and noticeable benefits early are more likely to remain satisfied with and continue therapy.

In earlier studies, zasocitinib had already demonstrated an advantage over Amgen’s Otezla, showing superior PASI 90 responses beginning at the 4th week.

The latest findings may add pressure on Sotyktu. In 2019, BMS opted to retain the then-investigational drug while divesting the blockbuster Otezla to secure regulatory approval for its acquisition of Celgene. After receiving FDA go-ahead in 2022, Sotyktu was projected by BMS to generate $4 billion in sales, but uptake has progressed more slowly than anticipated. The drug generated $291 million in revenue last year, reflecting a 5% decline in U.S. sales despite growth in international markets.

Competition has intensified in the space, with Johnson & Johnson and Protagonist Therapeutics’ IL-23 receptor antagonist, Icotyde, also outperforming Sotyktu before obtaining FDA approval in March.

Takeda expects to launch zasocitinib in the first half of 2027, while Alumis is pursuing a similar timeline for its own TYK2 inhibitor and plans to submit an FDA application in the fourth quarter.

This news comes a few days after a recent antitrust ruling led the firm to revise its 2025 financial outlook, leaving the drugmaker facing a loss of 152 billion Japanese yen (just under $950 million) for the fiscal year.

Takeda’s Inhibitor Shows Strong Results in Psoriasis Trial

Takeda’s latest clinical success has drawn significant attention after its investigational inhibitor outperformed Bristol Myers Squibb’s Sotyktu in a Phase 3 study involving patients with moderate-to-severe plaque psoriasis. The findings suggest that Takeda’s therapy could become a strong competitor in the growing psoriasis treatment market.

Takeda’s Demonstrates Superior Efficacy

According to trial results, Takeda’s inhibitor achieved higher rates of skin clearance and treatment response compared with Sotyktu. Researchers reported that more patients receiving Takeda’s therapy reached key clinical endpoints, reinforcing confidence in the drug’s effectiveness.

The success of Takeda’s candidate is particularly important as healthcare providers continue to seek treatments that deliver stronger outcomes while maintaining acceptable safety profiles.

Market Implications for Takeda’s Program

With competitive pressure increasing in the psoriasis market, Takeda’s strong Phase 3 performance may provide a valuable commercial advantage. The company is expected to continue discussions with regulatory authorities while preparing additional analyses of the study outcomes.

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