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     151  0 Kommentare Alector Doses First Patient in Pivotal Phase 3 INFRONT-3 Trial Evaluating AL001 in Patients with Frontotemporal Dementia - Seite 2

    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/.

    About AL001
    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 Alector and Adimab, LLC.

    AL001 has received Orphan Drug designation for the treatment of FTD and Fast Track designation for the treatment of FTD-GRN from the U.S. Food and Drug Administration.

    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 the United States and roughly 110,000 in the European Union. There are currently no FDA-approved treatments options for FTD.

    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.

    About Alector
    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 South San Francisco, California. For additional information, please visit www.alector.com.

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    Alector Doses First Patient in Pivotal Phase 3 INFRONT-3 Trial Evaluating AL001 in Patients with Frontotemporal Dementia - Seite 2 Trial will enroll up to 180 symptomatic and pre-symptomatic participants with FTD-GRN gene mutation at multiple sites in the U.S., Europe and Australia There are currently no FDA-approved treatments for frontotemporal dementia SOUTH SAN FRANCISCO, …