Alector, Inc. (Nasdaq: ALEC), a biotechnology company focused on developing therapies for neurodegenerative diseases, has outlined its strategic priorities for 2025, emphasizing advancements in its clinical and preclinical programs targeting frontotemporal dementia, Alzheimer's disease, Parkinson's disease, and Lewy body dementia. The company's approach leverages genetics, immunology, and neuroscience to develop therapies aimed at removing toxic proteins, replacing deficient proteins, and restoring immune and nerve cell function.
Key Clinical Program Updates
The pivotal Phase 3 INFRONT-3 trial of latozinemab, a monoclonal antibody designed to increase progranulin (PGRN) levels in the brain, is ongoing, with topline data expected in the fourth quarter of 2025. Latozinemab targets frontotemporal dementia with a granulin gene mutation (FTD-GRN), a condition caused by heterozygous loss-of-function mutations in the GRN gene, leading to PGRN haploinsufficiency. The drug has received Orphan Drug, Breakthrough Therapy, and Fast Track designations from the FDA.
Additionally, the Phase 2 PROGRESS-AD trial evaluating AL101/GSK4527226 in early Alzheimer's disease is progressing, with approximately 75% of the targeted 282 participants enrolled. Completion of enrollment is anticipated by mid-2025. AL101/GSK4527226, like latozinemab, aims to elevate PGRN levels in the brain by blocking and downregulating the sortilin receptor.
Advancing the Preclinical Pipeline
Alector is also focused on advancing its preclinical and research pipeline, utilizing its Alector Brain Carrier (ABC) technology platform to enhance therapeutic delivery to the brain. Key programs include:
- ADP037-ABC: An anti-amyloid beta (Aβ) antibody paired with ABC for Alzheimer's disease, designed to remove brain amyloid plaques and potentially reduce the risk of amyloid-related imaging abnormalities (ARIA).
- ADP050-ABC: A GCase replacement therapy paired with ABC for GBA gene mutation carriers with Parkinson's disease and Lewy body dementia, addressing deficient GCase activity.
- ADP056: A reelin modulator designed to block tau pathology and promote synaptic function in Alzheimer's disease.
- ADP063-ABC and ADP064-ABC: Therapeutic candidates targeting tau pathology in Alzheimer's disease through distinct approaches, including an anti-tau antibody and an anti-tau siRNA.
Financial Position
As of September 30, 2024, Alector reported $457.2 million in cash, cash equivalents, and investments, which is expected to fund operations through 2026. The company plans to provide further financial guidance during its fourth-quarter and full-year earnings conference call.
Management Commentary
"Alector remains steadfast in our mission to deliver transformative treatments for neurodegenerative diseases. As we begin 2025, we are focused on the significant milestones ahead," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. He highlighted the anticipated topline data readout for the INFRONT-3 Phase 3 trial of latozinemab and the progress of the Phase 2 PROGRESS-AD trial of AL101/GSK4527226 as key milestones for the company.
