Takeda to acquire Nimbus’ TYK2 inhibitor in deal worth $6bn

Takeda has announced it will acquire Nimbus Therapeutics' NDI-034858, an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor being evaluated for the treatment of multiple autoimmune diseases, in a deal worth $6bn.

Under the terms of the agreement, Takeda will make an upfront payment of $4bn to Nimbus, which will also be eligible for two $1bn milestone payments upon achieving annual net sales of $4bn and $5bn.

Nimbus recently announced positive top-line results from a phase 2b study evaluating NDI-034858, which will be known as TAK-279 upon completion of the transaction, for patients with moderate-to-severe plaque psoriasis.

Data from the 259 patients dosed in the study showed that NDI-034858 achieved the primary efficacy endpoint, with a statistically significant greater proportion of patients achieving a 75% improvement in skin lesions – compared to placebo at 12 weeks.

Additional endpoints in the study were also achieved, Nimbus reported, and the safety of NDI-034858 was consistent with other leading allosteric TYK2 inhibitors.

Takeda said it intends to present results from the study early in 2023, with NDI-034858 anticipated to enter a phase 3 study in psoriasis next year.

The candidate is also part of an ongoing phase 2b study in active psoriatic arthritis, and Takeda has outlined its plans to investigate it for the treatment of inflammatory bowel disease and other autoimmune diseases.

Commenting on the acquisition, Andy Plump, president of research and development at Takeda, said: “After having seen the NDI-034858 phase 2b data, particularly the PASI scores, we are excited by the differentiation of this molecule within the TYK2 class, and we believe in its broad potential for people with autoimmune diseases.

“By virtue of its unique allosteric mechanism of action, NDI-034858 is both a potent and highly selective TYK2 inhibitor with exceptional clinical activity, a strong tolerability profile and wide therapeutic margins. NDI-034858 is a potentially best-in-class TYK2 inhibitor across a wide range of immune mediated conditions.”

Earlier this month, Takeda’s dengue vaccine candidate, Qdenga (TAK-003), was approved by the European Commission for the prevention of dengue disease in individuals aged four years and over.

The decision, which followed a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in October, made Qdenga the only dengue vaccine approved in the EU for use in individuals regardless of previous dengue exposure.