Landmark results support TYK2 inhibitor as a leading psoriasis treatment
Takeda’s oral tyrosine kinase 2 (TYK2) inhibitor zasocitinib (TAK-279) has shown promise to deliver clear skin in a once-daily pill.
Phase III studies in adults with moderate-to-severe plaque psoriasis (PsO) have demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints, static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75, at week 16.
Zasocitinib had a significantly greater PASI 75 response rate seen as early as week 4 and continuing to increase through week 24.
The studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast.
“People living with psoriasis continue to seek safe, effective and fast-acting oral therapies. These landmark results support zasocitinib’s promise to become a leading oral treatment option that can deliver clear skin for patients with plaque psoriasis,” said Christophe Weber, President and Chief Executive Officer at Takeda. “This marks the third positive Phase III readout from our overarching pipeline this year. Each of these programmes – zasocitinib, oveporexton and rusfertide – has potential to transform patient lives, redefine medical practice and deliver significant revenue growth in the future.”
Takeda plans to submit a New Drug Application with the US Food and Drug Administration (FDA) and other regulatory authorities starting in 2026.
Zasocitinib maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways. It has more than one-million-fold greater selectivity for TYK2 compared to other JAK enzymes, which could maximise TYK2 inhibition without impacting JAK1, 2 and 3 signalling, based on in vitro data.
Takeda is currently evaluating zasocitinib in a head-to-head study against deucravacitinib in plaque psoriasis and in Phase III studies in psoriatic arthritis. In addition, Phase II studies are ongoing in Crohn’s disease, ulcerative colitis and vitiligo, and being initiated in hidradenitis suppurativa.
Diana Turner, Deputy Editor, DDW