On Tuesday, Alector, Inc. (NASDAQ:ALEC) announced results from the Phase 3 INFRONT-3 trial evaluating latozinemab (AL001) for frontotemporal dementia caused by a progranulin gene mutation (FTD-GRN).
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In the 96-week study, latozinemab, developed in collaboration with GSK plc (NYSE: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 (CDR plus NACC FTLD-SB).
Although treatment resulted in a statistically significant effect on the biomarker co-primary endpoint of plasma progranulin (PGRN) concentrations, the secondary and exploratory endpoints, such as fluid biomarkers and volumetric magnetic resonance imaging (vMRI), 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.
Based on these results, the open-label extension portion of the INFRONT-3 trial and the continuation study for latozinemab will be discontinued.
Alector Pipeline Outlook
In the ongoing collaboration with GSK, nivisnebart (AL101/GSK4527226) is being evaluated in PROGRESS-AD, a 76-week Phase 2 trial for early Alzheimer's disease (AD).
Enrollment was completed in April 2025; trial completion is expected in 2026. An independent interim analysis is planned for the first half of 2026.
Alector is reducing its workforce by approximately 49%.
The company estimates that its approximately $291.1 million in cash, cash equivalents, and short-term investments as of September 30, 2025, is expected to provide runway through 2027.
Analyst Take
William Blair downgraded Alector from Outperform to Market Perform. Analyst Myles Minter removed latozinemab in the FTD-GRN opportunity.
"We believe the study was well-executed, given both plasma and CNS PGRN elevations to normal levels were observed.
However, while PGRN insufficiency has been linked to FTD-GRN," Minter wrote in an investor on Wednesday.
Last year, Alector released results from the INVOKE-2 Phase 2 trial of AL002 in slowing disease progression in individuals with early Alzheimer's disease (AD).
AL002 failed to meet the primary endpoint of slowing Alzheimer's clinical progression as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB).
Price Action: Alector shares were down 51.09% at $1.57 at the time of publication on Wednesday. The stock is near its 52-week low of $0.87, according to Benzinga Pro data.
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