Alector Doses First Patient in Pivotal Phase 3 INFRONT-3 Trial Evaluating AL001 in Patients with Frontotemporal Dementia
- Trial will enroll up to 180 symptomatic and pre-symptomatic participants with FTD-GRN gene mutation at multiple sites in the
U.S., Europeand Australia
- There are currently no FDA-approved treatments for frontotemporal dementia
Frontotemporal Dementia (FTD) is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis. It affects 50,000 to 60,000 people in
“The initiation of our global pivotal Phase 3 trial of AL001 is a significant step towards achieving our mission of helping patients suffering from FTD and other neurodegenerative diseases,” said Robert Paul, M.D., Ph.D., chief medical officer of Alector. “Our Phase 3 study has been designed to measure slowing of disease progression in both symptomatic and pre-symptomatic FTD-GRN patients. We believe the INFRONT-3 trial will successfully demonstrate AL001’s ability to significantly alter the course of FTD and potentially transform the lives of people affected by this condition. We are incredibly grateful to the patients, healthcare professionals and clinical sites that participated during earlier phases of study, allowing us to rapidly progress to Phase 3 evaluation in less than two years.”
The randomized, double-blind, placebo-controlled trial will enroll up to 180 FTD-GRN mutation carriers across approximately 50 sites in
The primary endpoint of the pivotal Phase 3 trial is to measure the effect of AL001 on clinical decline by utilizing the CDR® plus NACC FTLD-SB assessment, which evaluates clinical impairments in behavior, language, memory, judgment, and functional activities in trial participants. In addition, the trial will assess secondary clinical endpoints, multiple biomarkers and safety.
To learn more about the Phase 3 trial, please visit https://clinicaltrials.gov/.
AL001 is a wholly owned, investigational human monoclonal antibody designed to modulate progranulin, a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, including FTD, Alzheimer’s disease, and Parkinson’s disease. AL001 aims to increase the level of progranulin in humans by inhibiting a progranulin degradation mechanism. AL001 was discovered and engineered in collaborative effort between
AL001 has received Orphan Drug designation for the treatment of FTD and Fast Track designation for the treatment of FTD-GRN from the
About Frontotemporal Dementia (FTD)
FTD is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis. It affects 50,000 to 60,000 people in
There are multiple heritable forms of FTD. In one form, FTD-GRN, people have a mutation in the progranulin gene. This population represents 5% to 10% of all people with FTD. Mutations in a single copy of progranulin gene (GRN) leads to a 50% or greater decrease in the level of progranulin and invariably leads to development of FTD. In another form, FTD-C9orf72, people with mutations in the C9orf72 gene can develop FTD, which represents approximately 5% to 10% of all people with FTD. FTD-C9orf72 is associated with abnormal accumulation of the protein TDP-43, which is also a hallmark pathology found in FTD-GRN.
Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. Alector is developing a broad portfolio of programs designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. The Company’s product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. Alector is headquartered in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to risks and uncertainties related to the Company’s plans for and anticipated benefits and mechanism of the Company’s product candidates, the timing and objectives of the Company’s clinical studies and anticipated regulatory and development milestones, Alector and its business as set forth in Alector’s Annual Report on Form 10-Q filed with the
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Source: Alector, Inc.