Takeda’s and Denali’s Alzheimer’s Drug Hit With Clinical Hold
The FDA has placed a clinical hold on Denali Therapeutics’ and Takeda Pharmaceutical’s experimental Alzheimer’s drug DNL919.
DNL919 is an antibody transport vehicle that activates the TREM2 receptor protein on myeloid cells to boost immune cell function in the brain. It is one of three potential neurodegenerative drug candidates Denali agreed to co-develop with Takeda in 2018.
Denali, which had hoped to launch human trials during the first half of this year, did not disclose the reason for the clinical hold.
South San Francisco–based Denali said it received an email from FDA stating that the agency had placed the IND application for DNL919 on clinical hold. The agency said it would send an official letter to the company within approximately 30 days.
On January 10, the company projected that it would produce the first clinical data for DNL919 in 2022.
The company also revealed that Takeda (NYSE:TAK) had exercised its option to co-develop and co-commercialize DNL919 in Alzheimer’s disease. Takeda and Denali announced a pact to partner on developing therapies for neurodegenerative diseases in 2018.
In mid-day trading, DNL shares had fallen 12.92% to $33.57.
The company Vigil Neuroscience (Cambridge, Massachusetts) is also developing a TREM2 agonist known as VGL101. The company also cites another unnamed small-molecule TREM2 agonist on its website.
January 18, 2022
