Alector announces AL002 trial misses endpoint, reduces workforce by 17%

Alector (ALEC) announced results from the INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease, or AD. Treatment with AL002 resulted in sustained target engagement and pharmacodynamic responses indicative of microglial activation. However, AL002 failed to meet the primary endpoint of slowing of Alzheimer’s clinical progression as measured by the Clinical Dementia Rating Sum of Boxes, and there were no treatment effects that favored AL002 on secondary clinical and functional endpoints. Similarly, there were no significant effects on Alzheimer’s fluid biomarkers favoring AL002, and amyloid PET imaging demonstrated no treatment-related reduction of brain amyloid levels. As previously reported, MRI changes resembling amyloid-related imaging abnormalities (ARIA) and infusion-related reactions were observed in INVOKE-2. The instances of ARIA were primarily seen in participants treated with AL002.Based upon the results, Alector is stopping the long-term extension study. Topline data from the pivotal INFRONT-3 Phase 3 clinical trial of latozinemab in frontotemporal dementia with a progranulin gene mutation is expected in late 2025 or early 2026. PROGRESS-AD, a global Phase 2 clinical trial evaluating AL101/GSK4527226 in early AD, has reached more than one-third of its target enrollment of 282 participants. Alector is also advancing its preclinical candidates aimed at a broad and diverse range of protein and enzyme targets. In addition to advancing its pipeline, the company is continuing to develop its blood-brain barrier technology platform, Alector Brain Carrier, or ABC. To align resources with these strategic priorities, Alector is reducing its workforce by approximately 17%. As of September 30, Alector has $457.2M in cash, cash equivalents, and investments, which the company continues to expect will provide runway through 2026. Alector plans to provide guidance for 2025 during its fourth-quarter and full-year earnings conference call.