Alector Initiates Phase 2 Trial of AL001 in Patients with Frontotemporal Dementia
“We are encouraged by the recent data from our Phase 1b trial of AL001, in which AL001 was well-tolerated and restored progranulin back to normal physiological levels in the central nervous system of FTD-GRN patients,” said
The Phase 2 trial will assess the longitudinal safety, tolerability, pharmacokinetics and pharmacodynamics of AL001, as well as its effects on biomarkers of neurodegeneration and on cognition. The study will enroll FTD-GRN patients and an additional cohort of
“FTD is a devastating brain disorder that leads to a rapid and progressive decline of brain function in affected individuals and for which no treatment exists today. AL001 is a completely novel approach for the treatment of
About the INFRONT Phase 2 Study
The INFRONT Phase 2 multicenter, open-label clinical trial of AL001 is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect on clinical outcome assessments (COAs) in frontotemporal dementia patients with a granulin or C9orf72 mutation. AL001 will be administered intravenously every four weeks over at least a 48-week dosing period. To learn more about this study, please visit www.clinicaltrials.gov and reference study number NCT03987295. An open-label extension study is planned to be offered to study participants following completion of this Phase 2 trial.
ARTFL-LEFFTDS and GENFI investigators are valued partners to
About Frontotemporal Dementia (
There are multiple heritable forms of
AL001 is Alector’s wholly-owned human monoclonal antibody designed to modulate progranulin, a regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, including
AL001 was granted Orphan Drug designation by the
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Source: Alector, Inc.