FDA places Alzheimer’s therapeutic IND Application on hold

pharmafile | January 17, 2022 | News story | Sales and Marketing  

The FDA has placed a hold on the Investigational New Drug (IND) application for DNL919, indicating they will provide an official clinical hold letter to Denali Therapeutics in approximately 30 days. Denali had hoped to begin fist-in-human clinical trials for its therapeutic DNL919, under development for the treatment of Alzheimer’s disease (AD).

Denali plans to provide additional updates, pending discussion with the FDA. A few days prior to the hold, on 10 January, the company projected that it would produce the first clinical date for the therapeutic in 2022. Denali predicted that human safety and biomarker data would be available on DNL919 in the second half of 2022.

The company also revealed during this presentation, that Takeda had exercised its option in December 2021 to co-develop and co-commercialise DNL919 in Alzheimer’s disease. In January 2018, the companies announced a pact to partner in the development of therapies for neurodegenerative diseases.

An Investigational New Drug Application is a request from a clinical study sponsor to obtain authorisation from the FDA to administer an investigational drug, or biological product, to people. Unless exempted, the sponsor for a clinical study must obtain authorisation from the FDA for conducting the study, by submitting an IND Application.

DNL919 is an Antibody Transport Vehicle (ATV) designed to activate TREM2 and improve microglial function. TREM2 is a receptor expressed on microglia, which are immune cells of the brain. Genetic mutations in TREM2 that result in loss of function are significantly linked with an increased risk of Alzheimer’s disease.

Alzheimer’s disease is a progressive brain disorder which causes problems with memory, thinking and behavior. While treatments exist to help manage the condition, there is no known cure. The exact cause of the disease is not yet fully understood, though increasing age, family history, untreated depression, and lifestyle factors associated with cardiovascular disease, are all thought to increase risk of developing the condition.

Ana Ovey

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