Alector Completes Enrollment in Phase 2 Trial for Early Alzheimer's Drug AL101

Alector, Inc., a biotechnology company based in South San Francisco, has reached a significant milestone in its efforts to combat neurodegenerative diseases. The company recently announced the successful early completion of participant enrollment in the PROGRESS-AD Phase 2 clinical trial. This 76-week trial is designed to assess the safety and efficacy of AL101/GSK4527226, a promising progranulin-elevating candidate, in slowing the progression of early-stage Alzheimer’s disease (AD).

In collaboration with GSK, Alector is exploring the potential of AL101, an investigational human monoclonal antibody that targets the sortilin receptor. By blocking and downregulating this receptor, AL101 aims to increase progranulin (PGRN) levels in the brain. Research has indicated that reduced levels of PGRN, due to mutations in the GRN gene, are linked to a heightened risk of developing Alzheimer's disease. Conversely, higher levels of PGRN have demonstrated protective effects in animal models.

Arnon Rosenthal, Ph.D., CEO of Alector, emphasized the importance of this milestone, noting that it brings the team closer to evaluating the impact of AL101 on disease progression. This achievement further underscores Alector’s commitment to pioneering first-in-class therapies for Alzheimer’s disease and improving the quality of life for individuals affected by this debilitating condition.

The PROGRESS-AD trial is a randomized, double-blind, placebo-controlled study being conducted on a global scale by GSK. Participants are randomly assigned to receive either one of two dose levels of AL101 or a placebo, administered intravenously. The primary focus of the trial is to measure disease progression using the Clinical Dementia Rating Sum of Boxes (CDR-SB), a recognized tool for tracking cognitive impairment progression. The study also evaluates additional clinical and functional outcomes to provide a comprehensive understanding of AL101’s effects.

AL101/GSK4527226 is an innovative investigational treatment developed to potentially address various neurodegenerative disorders. Its mechanism involves elevating PGRN levels, a protein crucial for regulating lysosomal function, neuronal survival, and inflammation. Given its genetic links to neurodegeneration, PGRN elevation is being explored as a strategy not only for Alzheimer's but also for other diseases such as Parkinson’s.

The collaboration between Alector and GSK began in July 2021, with a focus on the global development and commercialization of progranulin-elevating monoclonal antibodies, including AL101 and latozinemab. Under this agreement, Alector received a significant upfront payment and stands to gain further financial benefits through milestone-related payments. The companies have agreed to equally share profits and losses from the commercialization of these treatments in the United States, while Alector will receive tiered royalties from sales outside the U.S.

Alector is committed to leveraging its expertise in genetics, immunology, and neuroscience to advance a portfolio of programs aimed at combating neurodegenerative diseases. The company is also developing the Alector Brain Carrier (ABC) platform to enhance the delivery of therapeutics across the blood-brain barrier, aiming for better efficacy at lower doses and improved patient outcomes.

Headquartered in South San Francisco, Alector is at the forefront of developing innovative therapies that address the underlying causes of neurodegeneration, offering hope for patients affected by these challenging diseases.