Dec. 05, 2019: U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Alecto’s investigational therapeutic, AL001, for the treatment of patients with frontotemporal dementia (FTD) carrying specific genetic mutations in the granulin gene (FTD-GRN).
It is currently evaluated in a Phase 2 trial for the treatment of FTD-GRN and FTD-C9orf72. Fast Track designation is intended to facilitate the development and accelerate the review of therapies for serious conditions and fill an unmet medical need.
Programs with Fast Track designation possibly will benefit from the early and frequent communications with the FDA, potential priority review, and additionally a rolling submission of the marketing application.
AL001 is a monoclonal antibody designed to modulate progranulin, a regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, including FTD, Alzheimer’s disease, and Parkinson’s disease.
It increases the level of progranulin in humans by inhibiting a progranulin degradation mechanism, AL001 discovered and engineered in collaboration of Alector and Adimab, LLC. https://fda.einnews.com/pr_news/504092810/alector-announces-fda-fast-track-designation-granted-to-al001-for-the-treatment-of-patients-with-frontotemporal-dementia