Alector Announces Achievement of Target Enrollment in the Pivotal INFRONT-3 Phase 3 Clinical Trial of Latozinemab in Individuals with Frontotemporal Dementia Due to a Progranulin Gene Mutation (FTD-GRN)

--101 symptomatic FTD-GRN participants enrolled in INFRONT-3 --

SOUTH SAN FRANCISCO, Calif., Oct. 27, 2023 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that it has achieved target enrollment in INFRONT-3, the pivotal Phase 3 clinical trial of latozinemab (AL001). INFRONT-3 is evaluating the safety and efficacy of latozinemab in slowing disease progression in individuals with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). Latozinemab is an investigational human monoclonal antibody designed to block sortilin, a degradation receptor for progranulin (PGRN). It is intended to elevate PGRN levels and enhance the activity of microglia, the primary cells of the brain’s innate immune system. Latozinemab is the most advanced PGRN modulating product candidate in clinical trials and the most advanced potential treatment for FTD-GRN. Latozinemab is being developed in collaboration with GSK.

Earlier this year, Alector and GSK held a Type C meeting with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA) regarding INFRONT-3. The companies aligned with the FDA and EMA to conduct the primary analysis on symptomatic FTD-GRN participants, supporting an enrollment target of approximately 90-100 symptomatic participants in INFRONT-3. Alector and GSK achieved target enrollment in INFRONT-3 with 101 symptomatic participants.

“Decreased progranulin levels due to genetic mutations in the progranulin gene are a known cause of FTD, a rare and rapidly progressing neurodegenerative disease, which is the most common form of dementia for people under the age of 60,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “By achieving target enrollment in INFRONT-3, we are an important step closer to generating data from this pivotal trial of latozinemab, which could pave the way for registration. Currently, there are no approved treatment options available for any form of FTD, and we are eager to learn more about the potential of latozinemab.”

INFRONT-3 is a pivotal, randomized, double-blind, placebo-controlled Phase 3 clinical trial, which is enrolling symptomatic and at-risk FTD-GRN participants at multiple sites across North America, Europe, Argentina and the Asia-Pacific region. Participants are randomized to receive latozinemab or placebo intravenously every four weeks for the duration of the 96-week trial and are being given the option to continue receiving treatment in the open-label extension (OLE) study after the 96-week treatment period. Following the 96-week OLE, if completed, participants will have another opportunity to roll over into a continuation study. The primary endpoint in INFRONT-3 is disease progression as measured by the Clinical Dementia Rating scale plus National Alzheimer’s Disease Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR plus NACC FTLD-SB). The CDR plus NACC FTLD-SB, which is used to assess (score) the severity of FTD, is a validated instrument that assesses both cognitive and functional domains and has been accepted as the efficacy endpoint for FTD-GRN by the FDA and EMA. The trial also employs other clinical and functional outcome assessments. Additionally, the trial includes cerebrospinal fluid (CSF) and plasma biomarkers assessing PGRN levels, along with multiple disease-relevant biomarkers of lysosomal function, complement activation, astrocyte function, neurodegeneration, and brain atrophy.