Alector has completed subject enrolment in the 76-week, randomised, Phase II PROGRESS-AD trial, which is assessing the efficacy and safety of AL101/GSK4527226, in individuals with early Alzheimer’s disease (AD).
AL101, a human monoclonal antibody, is being jointly developed by the company and GSK.
The trial is designed to assess two dose levels of the antibody, with subjects receiving the intravenous administration of either the antibody or a placebo.
Its primary endpoint is the measurement of disease progression using the Clinical Dementia Rating Sum of Boxes (CDR-SB), an instrument that tracks cognitive impairments in several categories.
Other clinical and functional outcome evaluations will also be measured in the trial.
GSK is carrying out this double-blind, placebo-controlled trial at several worldwide sites.
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By GlobalDataAccording to Alector, AL101 aims to block and downregulate the sortilin receptor, thereby raising progranulin (PGRN) levels in the brain.
A modest decrease in PGRN levels due to GRN gene mutations is related to an increased AD development risk.
Alector entered into a partnership and licence agreement with GSK in July 2021.
As per this agreement, Alector obtained $700m in upfront and qualified for up to an additional $1.5bn in milestone payments.
Alector CEO Arnon Rosenthal said: “In partnership with GSK, we are pleased to announce the completion of enrolment ahead of schedule in the PROGRESS-AD Phase II clinical trial of AL101, marking an important milestone in our pursuit of developing first-in-class therapies for AD.
“This achievement brings us one step closer to assessing the potential of AL101 in slowing disease progression and to furthering our understanding of AL101’s effects on individuals living with this devastating condition. We remain committed to advancing our progranulin-elevating candidate and evaluating its impact in the ongoing trial.”
In 2023, Alector completed enrolment in the Phase II INVOKE-2 trial of AL002 for the treatment of early AD.
