Alector, GSK announce FDA granted BTD to latozinemab

Alector (ALEC) and GSK plc (GSK) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to latozinemab, an investigational human monoclonal antibody designed to block sortilin to elevate progranulin, PGRN, levels for the potential treatment of frontotemporal dementia with a progranulin gene mutation, FTD-GRN. “In partnership with GSK, we are encouraged and excited by this FDA Breakthrough Designation. FTD-GRN is a rare and rapidly progressing neurodegenerative disease and one of the most common causes of early onset dementia,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “With this designation, we look forward to continued productive conversations with the FDA, recognizing the unmet need for people living with FTD-GRN, a serious condition for which there are no FDA-approved treatment options available. Latozinemab, the most advanced progranulin-elevating candidate in clinical development for FTD-GRN, is currently being studied in the pivotal INFRONT-3 Phase 3 study, which achieved target enrollment in October 2023.”