Alector Announces First Patient Dosed in PROGRESS-AD Phase 2 Clinical Trial of AL101/GSK4527226 in Patients with Early Alzheimer’s Disease
“In partnership with GSK, we are delighted to announce the dosing of the first patient in PROGRESS-AD, the Phase 2 trial of AL101 for the treatment of early Alzheimer’s disease, which remains a high unmet need,” said
PROGRESS-AD is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of AL101 enrolling approximately 282 patients with early Alzheimer’s disease at multiple sites globally. The 76-week study is designed to assess the safety and efficacy of two dose levels of AL101 compared to placebo. Participants will be randomized to one of three treatment groups, receiving AL101 or placebo intravenously. The primary endpoint of the study is disease progression as measured by the Clinical Dementia Rating Sum of Boxes (CDR®-SB). The CDR-SB is a validated instrument that tracks the progression of cognitive impairments in various categories. The trial also employs other clinical and functional outcome assessments.
The Phase 1 study of AL101 was a randomized, double-blind, placebo-controlled study in 88 healthy volunteers who received either single or multiple doses of AL101 administered intravenously (IV) or subcutaneously (SC). The study found that AL101 was generally well tolerated and increased progranulin (PGRN) levels in plasma and cerebrospinal fluid (CSF) in a dose-dependent manner. The study results demonstrated that the PK and PD profile supported the progression to Phase 2 clinical trials for more prevalent neurodegenerative conditions, such as AD and Parkinson’s disease.
Additional information about PROGRESS-AD (NCT06079190) may be found at ClinicalTrials.gov.
About AL101
AL101 is an investigational human monoclonal antibody designed to elevate the level of progranulin, a regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders. Mutations that moderately reduce the expression levels of progranulin have been shown to increase the risk of developing Alzheimer’s disease and Parkinson’s disease. Increased progranulin levels have been demonstrated to be protective for these diseases in animal models.
Collaboration with GSK
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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 has discovered and is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable rejuvenated immune cells to counteract emerging brain pathologies. Alector’s immuno-neurology product candidates are supported by biomarkers and seek to treat indications, including Alzheimer’s disease and genetically defined frontotemporal dementia patient populations. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our product candidates, our and our investigators' judgments and beliefs regarding the observed safety and efficacy to date of our product candidates, planned and ongoing preclinical studies and clinical trials, expected milestones, including the timing of data from the PROGRESS-AD Phase 2 trial, and expectations of our collaborations. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector’s Quarterly Report on Form 10-Q filed on
Alector Contacts:
Alector
202-549-0557
katie.hogan@alector.com
1AB (media)
973-271-6085
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212-600-1902
alector@argotpartners.com
Source: Alector, Inc.