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Alector Announces Topline Results from Phase 3 INFRONT-3 Clinical Trial Evaluating Latozinemab
Yahoo Finance· 2025-10-31 09:42
Core Insights - Alector Inc. is highlighted as a promising investment opportunity under $3, particularly following the announcement of topline results from the Phase 3 INFRONT-3 clinical trial for its drug latozinemab (AL001) targeting frontotemporal dementia due to a progranulin gene mutation [1][4] Clinical Trial Results - The INFRONT-3 trial, a 96-week double-blind study conducted in collaboration with GSK, did not achieve its primary endpoint of slowing the progression of frontotemporal dementia as measured by the Clinical Dementia Rating plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes [2][3] Future Developments - Alector is also involved in the PROGRESS-AD trial, a global 76-week Phase 2 study evaluating nivisnebart (AL101/GSK4527226) for early Alzheimer's disease, with enrollment completed in April 2025 and trial completion expected in 2026, including an independent interim analysis planned for H1 2026 [3]
Clinical Failure Halts Alector's Dementia Program, Company Reduces Workforce
Benzinga· 2025-10-22 16:07
Core Insights - Alector, Inc. announced results from the Phase 3 INFRONT-3 trial for latozinemab (AL001) targeting frontotemporal dementia caused by a progranulin gene mutation, which did not meet its primary clinical endpoint [1][2] Trial Results - The 96-week study did not achieve the 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 [2] - Although there was a statistically significant effect on the biomarker co-primary endpoint of plasma progranulin concentrations, secondary and exploratory endpoints showed no treatment-related effects on FTD-GRN [3] - Preliminary safety data did not indicate major safety concerns, but further analysis is ongoing [3] Future Plans - The open-label extension of the INFRONT-3 trial and the continuation study for latozinemab will be discontinued based on the trial results [4] - Alector is collaborating with GSK on nivisnebart (AL101/GSK4527226) in a 76-week Phase 2 trial for early Alzheimer's disease, with trial completion expected in 2026 [5] Financial Outlook - As of September 30, 2025, Alector has approximately $291.1 million in cash and equivalents, expected to provide financial runway through 2027 [6] Analyst Commentary - William Blair downgraded Alector from Outperform to Market Perform, with analyst Myles Minter removing latozinemab from the FTD-GRN opportunity [7] - Despite observing plasma and CNS PGRN elevations to normal levels, the link between PGRN insufficiency and FTD-GRN remains uncertain [7] Stock Performance - Following the announcement, Alector shares fell by 51.09% to $1.57, nearing a 52-week low of $0.87 [8]
Alector Announces Topline Results from Latozinemab Phase 3 Trial in Individuals with Frontotemporal Dementia Due to a GRN Mutation and Provides Business Update
Globenewswire· 2025-10-21 20:05
Core Insights - Alector, Inc. announced that its Phase 3 INFRONT-3 clinical trial of latozinemab (AL001) for frontotemporal dementia due to a progranulin gene mutation did not meet its primary clinical endpoint, although it showed a significant effect on plasma progranulin biomarker levels [2][3][14] Company Updates - The INFRONT-3 trial was a 96-week, double-blind study that failed to demonstrate clinical benefits in slowing disease progression, leading to the discontinuation of the open-label extension and continuation study for latozinemab [2][3] - Alector's pipeline includes ongoing collaboration with GSK on nivisnebart (AL101/GSK4527226) in a Phase 2 trial for early Alzheimer's disease, with completion expected in 2026 [6] - Alector is advancing multiple preclinical programs, including AL137 for anti-amyloid beta therapy and AL050 for enzyme replacement therapy in Parkinson's disease, with IND submissions targeted for 2026 and 2027 respectively [8][9] - The company is also developing a proprietary blood-brain barrier technology platform, Alector Brain Carrier (ABC), aimed at enhancing therapeutic delivery to the brain [7][17] Leadership and Workforce Changes - Alector is reducing its workforce by approximately 49% to focus resources on high-priority programs [10][11] - Sara Kenkare-Mitra, President and Head of R&D, will resign effective December 22, 2025, after contributing significantly to the company's R&D efforts [12][13] Financial Position - As of September 30, 2025, Alector reported approximately $291.1 million in cash and equivalents, expected to fund operations through 2027 [13]