Alector and GSK have completed enrollment in their Phase 2 PROGRESS-AD trial, evaluating AL101/GSK4527226 for early-stage Alzheimer’s disease. The trial is investigating the safety and efficacy of AL101, a monoclonal antibody designed to increase progranulin (PGRN) levels in the brain, a protein linked to a lower risk of developing Alzheimer’s. Enrollment finished ahead of schedule.
This accelerated enrollment underscores the urgent need for effective Alzheimer’s treatments and the industry’s growing interest in PGRN as a potential therapeutic target. Successfully demonstrating AL101’s efficacy could significantly impact the Alzheimer’s treatment landscape, potentially offering a new mechanism of action for this devastating disease. Moreover, the positive enrollment momentum could expedite the drug development timeline, bringing a promising therapy to patients sooner.
The 76-week, randomized, double-blind, placebo-controlled trial is evaluating two doses of AL101 administered intravenously. The primary endpoint is disease progression measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB). The trial also incorporates other clinical and functional assessments. AL101 aims to elevate PGRN by blocking the sortilin receptor, addressing the observation that reduced PGRN is associated with increased Alzheimer’s risk. Preclinical studies have indicated the neuroprotective potential of increased PGRN levels. The collaboration between Alector and GSK involves significant financial milestones and profit-sharing agreements, reflecting the potential commercial value of AL101.
The successful and rapid completion of enrollment in the PROGRESS-AD trial is a critical step forward for Alector and GSK. Positive results could validate PGRN as a viable therapeutic target, opening new avenues for Alzheimer’s drug development. This progress reinforces the potential of AL101 to offer a much-needed treatment option for individuals with early-stage Alzheimer’s and potentially other neurodegenerative conditions. The upcoming trial results are highly anticipated and could significantly influence the future of Alzheimer’s research and treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
