Alector discontinues extension portion of INFRONT-3 trial

Alector (ALEC) announced results from the Phase 3 INFRONT-3 clinical trial evaluating latozinemab in individuals with frontotemporal dementia due to a progranulin gene mutation. In the 96-week, double-blind INFRONT-3 trial, latozinemab, developed in collaboration with GSK, did not meet the clinical co-primary endpoint of slowing FTD-GRN progression, as measured by the Clinical Dementia Rating plus National Alzheimer’s Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes. Although treatment resulted in a statistically significant effect on the biomarker co-primary endpoint of plasma progranulin concentrations, the secondary and exploratory endpoints, such as fluid biomarkers and volumetric magnetic resonance imaging, demonstrated no treatment-related effects on FTD-GRN. Preliminary safety data have not highlighted any major safety concerns at present. More in-depth analysis of the data is ongoing.”While latozinemab did not demonstrate a clinical benefit in INFRONT-3, the insights gained are invaluable for understanding progranulin-related neurodegeneration,” said Giacomo Salvadore, M.D., Chief Medical Officer of Alector. “We extend our deepest gratitude to the patients, caregivers, and investigators who made this trial possible, and we plan to share the results with the scientific community to support continued progress in understanding progranulin biology and FTD pathophysiology.” Based on these results, the open-label extension portion of the INFRONT-3 trial and the continuation study for latozinemab will be discontinued.