Takeda plans filings for Sotyktu rival on new psoriasis data

Armed with positive results in two phase 3 trials, Takeda intends to file for approval of its oral psoriasis therapy zasocitinib in the US and other countries next year, with Bristol Myers Squibb's Sotyktu in its sights.

Once-daily zasocitinib, described as a second-generation TYK2 inhibitor, met all its safety and efficacy objectives in patients with moderate-to-severe plaque psoriasis in the two LATITUDE studies. According to Takeda, the results could "catalyse a new era of treatment" for the skin disorder.

Zasocitinib has been pitched as one of the top growth prospects for the Japanese pharma group, with potential across a range of inflammatory indications, including psoriatic arthritis, Crohn's disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa (HS). It is one of three priority programmes at the company, along with oveporexton or narcolepsy and polycythemia vera candidate rusfertide.

Compared to Sotyktu (deucravacitinib), which was approved by the FDA for plaque psoriasis in 2022 and brought in sales of more than $200 million in the first nine months of this year, zasocitinib is claimed to offer greater selectivity that promises to reduce side effects, as well as more sustained TYK2 inhibition lasting a full 24 hours.

The new data trumpeted by Takeda includes that more than half of study participants in the two LATITUDE trials treated with zasocitinib achieved clear or almost clear skin (a Psoriasis Area and Severity Index [PASI] 90 response), while on average, approximately 30% of them achieved completely clear skin (PASI 100) by week 16.

Compared to placebo, the TYK2 inhibitor also showed significant improvements in static Physician Global Assessment (sPGA) 0/1, a PASI 75 response seen as early as week four that increased through to week 24, and 44 secondary endpoints.

It was also shown to improve on older oral psoriasis therapy, Amgen's PDE 4 inhibitor Otezla (apremilast), which is still a blockbuster with third-quarter sales of $585 million and can be used across mild to severe psoriasis.

"People living with psoriasis continue to seek safe, effective, and fast-acting oral therapies," said Christophe Weber, president and chief executive at Takeda, who is retiring in 2026 and will hand the reins over to Julie Kim.

"These landmark results support zasocitinib's promise to become a leading oral treatment option that can deliver clear skin for patients with plaque psoriasis," added Weber.

Takeda is also running a head-to-head study of zasocitinib against Sotyktu in psoriasis, along with phase 3 studies in psoriatic arthritis and phase 2 studies in Crohn's disease and ulcerative colitis.

Image by Eszter Miller from Pixabay