FDA Rejects Denali and Takeda’s Alzheimer’s Drug DNL919 from Entering Clinical Trials

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On January 12, 2022, Eastern Time, the FDA rejected Denali Therapeutics and Takeda's jointly developed Alzheimer's disease drug DNL919 from entering clinical trials.

Takeda and Denali Therapeutics reached a collaboration agreement in January 2018, under which Denali received an upfront payment of $150 million from Takeda. In January 2021, Denali began a series of preparatory experiments to advance DNL919 into clinical trials, for which Takeda paid $8 million. Takeda placed high hopes on DNL919 and exercised its option from the 2018 contract at the end of 2021, deciding to co-develop the drug with Denali.

Denali was also confident in DNL919. Just this Monday (January 10) at the J.P. Morgan Annual Healthcare Conference, Denali announced that DNL919 is an Antibody Transport Vehicle (ATV), planned to enter clinical trials in the first half of this year, with safety and biomarker data expected to be available in the second half of the year.

This South San Francisco-based biotech company disclosed the news on Wednesday morning after receiving an email from the FDA on Tuesday after the market closed. Denali expects to receive a formal letter rejecting its drug from entering clinical trials in about 30 days.

ATV Drugs Aim to Activate TREM2 to Improve Microglial Function, Considered the "Brain's Resident Immune Cells." According to Denali, Loss of TREM2 Receptor Function Is Associated with an Increased Risk of Alzheimer’s Disease.

Denali said in this week's J.P. Morgan presentation that DNL919 is one of seven molecules it hopes to test in clinical trials this year. Other companies have drugs under research for treating Parkinson’s disease, amyotrophic lateral sclerosis, and frontotemporal dementia, among others.

For Takeda, this is not the first setback for the pharmaceutical company in Alzheimer's drug development. A few years ago, Takeda and its partner Zinfandel Pharmaceuticals failed to convert an already approved diabetes drug into a treatment for Alzheimer’s disease and canceled a Phase III trial named TOMORROW in January 2018.

Over the past year, the Alzheimer's disease field has garnered significant interest from investors and the pharmaceutical industry, especially since the FDA gave Biogen's Aduhelm a controversial green light. The drug has faced pressure from all sides. This week, the Centers for Medicare & Medicaid Services (CMS) decided that Medicare will only cover Aduhelm for use in qualifying clinical trials.

Reference Source: FDA Denies Denali's Takeda-Partnered Alzheimer's Drug from Entering Clinic