Feb. 05, 2020: Alector, Inc., a clinical-stage biotechnology company pioneering immuno-neurology announced that the U.S.FDA has granted Fast Track designation to AL101 for the treatment of patients with progranulin gene mutations causative of frontotemporal dementia (FTD-GRN).
AL101, the company’s second product candidate designed in order to restore progranulin levels in the brain, is currently being evaluated in a Phase 1 trial in healthy volunteers.
“There is a clear and validated connection between progranulin expression in the brain and certain neurodegenerative disorders like FTD, Alzheimer’s disease and Parkinson’s disease.
At Alector, we are pioneering the development of the therapies targeting the progranulin pathway, with two product candidates being tested in the clinical trials,”
“AL101 is the second product candidate from our progranulin program in order to receive Fast Track designation from the FDA, underscoring the need for the new treatment options for these patients.
We look forward to working with the agency to advance AL101 as quickly as possible.”Fast Track designation is designed to facilitate the development and expedite the review of therapies for the serious conditions and fill an unmet medical need.
Programs with Fast Track designation may benefit from the early and frequent communications with the FDA, potential priority review, and additionally a rolling submission of the marketing application.
About AL101: AL101 is Alector’s wholly-owned human monoclonal antibody and second product designed in order to restore levels of progranulin in the central nervous system. Progranulin is a regulator of the immune activity in brain with genetic links to the multiple neurodegenerative disorders.
AL101 received orphan drug designation from the U.S. FDA for the treatment of frontotemporal dementia in July 2019 and Fast Track designation in Feb. 2020.
https://fda.einnews.com/pr_news/508958705/alector-announces-fda-fast-track-designation-granted-to-al101-for-the-treatment-of-patients-with-frontotemporal-dementia
