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.