To be renamed TAK-279 after the completion of the deal, NDI-034858 is being studied for the treatment of various autoimmune diseases and has recently met the primary efficacy endpoint of a mid-stage trial in moderate-to-severe plaque psoriasis
Takeda to acquire a TYK2 inhibitor called NDI-034858 from Nimbus Therapeutics. (Credit: Lombroso/Wikimedia Commons)
Takeda has agreed to acquire NDI-034858, an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor, from Nimbus Therapeutics in a deal worth up to $6bn.
To be renamed TAK-279 after the closing of the deal, NDI-034858 is being studied for the treatment of various autoimmune diseases.
Recently, the TYK2 inhibitor delivered positive results in a phase 2b trial in moderate-to-severe plaque psoriasis.
Data from the 259 patients subjected to NDI-034858 showed that the drug candidate achieved the primary efficacy endpoint of the mid-stage trial. This was after a statistically significant greater proportion of patients achieved PASI-75, compared to placebo at 12 weeks.
Takeda plans to showcase results from the phase 2b study in early 2023.
The Japanese pharma company expects NDI-034858 to enter phase 3 clinical development in psoriasis next year.
Currently, the TYK2 inhibitor is being evaluated in a phase 2b study in active psoriatic arthritis.
Takeda also intends to investigate the drug candidate for the treatment of inflammatory bowel disease (IBD) and other autoimmune diseases.
Takeda president and CEO Christophe Weber said: “Adding this TYK2 inhibitor to our late-stage pipeline gives Takeda an exciting program that has the potential to significantly expand our portfolio and patient impact, while enhancing our growth strategy beyond ENTYVIO.
“We are confident we can execute a broad development program and deliver a best-in-class therapy for these patients, given Takeda’s strong background in immune-mediated diseases, including IBD.”
As per the terms of the deal, Nimbus Therapeutics will be paid $4bn upfront by Takeda. This will be followed by two milestone payments of $1bn each should the drug candidate achieve annual net sales of $4bn and $5bn.
Nimbus Therapeutics CEO Jeb Keiper said: “Nimbus’ allosteric TYK2 inhibitor has the potential to be a best-in-class medicine in multiple disease areas, and we are confident that Takeda’s commitment and capabilities will enable NDI-034858 to reach its full value to patients.
“The proposed acquisition highlights Nimbus’ ability to discover and develop high-value investigational medicines leveraging our computational structure-based drug design and development engine.”
The deal, which is subject to Hart-Scott-Rodino (HSR) and other antitrust clearances, is expected to close by the end of FY2022.