On 25 November, Alector, a clinical-stage biotechnology company focused on developing therapies for the treatment of neurodegenerative diseases, announced results from its INVOKE-2 Phase 2 clinical trial, which evaluated the safety and efficacy of AL002 in people with early Alzheimer’s disease (AD). INVOKE-2 was a randomised, double-blind, placebo-controlled, dose-ranging and multi-center trial conducted across 11 countries including several EU countries. The trial aimed to assess whether AL002 could slow disease progression in early AD, with participants receiving either AL002 or a placebo intravenously for up to 96 weeks.
The trial did not meet its primary endpoint of slowing disease progression, as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB). AL002 also showed no significant effects on secondary endpoints or biomarkers. Despite this, the treatment with AL002 demonstrated sustained target engagement and evidence of microglial activation. MRI scans indicated amyloid-related imaging abnormalities (ARIA) in some participants, particularly those treated with AL002. Additionally, infusion-related reactions were observed. Following these results, Alector announced the termination of the long-term extension study for AL002. The company will now focus its efforts on other clinical trials, including the INFRONT-3 Phase 3 trial of latozinemab in frontotemporal dementia and the PROGRESS-AD Phase 2 trial of AL101/GSK4527226 in early AD. Topline data from INFRONT-3 is expected in late 2025 or early 2026.