Latozinemab

Alzamend Neuro to present non-clinical data on AL001, a lithium-based treatment, at the Society of Toxicology 2025 Annual Meeting, showing enhanced brain-specific lithium delivery with minimized systemic exposure and no adverse effects. The company plans five Phase II trials in 2025 targeting Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD, aiming for FDA 505(b)(2) approval.

AL001, a lithium salicylate/L-proline co-crystal, shows promise for treating bipolar disorder, Alzheimer’s, major depressive disorder, and PTSD by enhancing brain lithium delivery while minimizing systemic exposure. Alzamend Neuro's study indicates AL001's potential for safer, more effective lithium therapy, with upcoming Phase II trials in 2025.

Alzamend Neuro reported Q2 2025 financial results, showing $8.3M net cash from financing, $3.8M stockholder equity, and $4.1M cash position. The company secured $25M in preferred stock and $6.5M in at-the-market sales agreements, regaining Nasdaq compliance and preparing for five clinical trials in 2025, including Phase II trials for AL001 at Massachusetts General Hospital and resumption of ALZN002 trials.

Alector’s Phase II INVOKE-2 trial for Alzheimer’s therapy AL002 failed to meet primary endpoint, leading to discontinuation of long-term extension trial and 17% workforce reduction. The company plans to focus on monoclonal antibodies programs with GSK, including latozinemab for frontotemporal dementia and AL101 for early Alzheimer’s. Alector’s stock dropped 31% post-announcement.

Alzamend Neuro identified the maximum tolerated dosage of AL001, a lithium therapy for Alzheimer’s and other disorders, which avoids intensive drug monitoring. AL001, a novel lithium formulation, was well-tolerated in a Phase 1/2 trial, with a maximum tolerated dose of 240 mg lithium carbonate equivalent taken three times daily. Alzamend plans to test this dose in five Phase 2 trials for Alzheimer’s, bipolar disorder, major depressive disorder, and PTSD, in partnership with Massachusetts General Hospital.

Alzamend Neuro partners with Massachusetts General Hospital for a Phase II clinical trial of AL001, a next-generation lithium therapeutic for bipolar disorder, with Dr. Ovidiu Andronesi as principal investigator. The study aims to compare AL001's safety and effectiveness to current lithium products by analyzing lithium levels in the brain.

Alzamend Neuro partners with Massachusetts General Hospital for a Phase 2 trial of AL001, an oral therapy for Alzheimer’s-related dementia. The trial aims to determine the minimum effective dose and safety profile of AL001, a novel lithium-delivery system, compared to marketed lithium. Preclinical studies show AL001 prevents cognitive impairment and improves learning and memory in mouse models of Alzheimer’s. A completed Phase 1/2 trial suggests AL001 is well-tolerated and achieves similar blood lithium levels to marketed lithium at lower doses.

Latozinemab, developed by Alector, Inc. and GSK, received FDA Breakthrough Therapy Designation for treating FTD-GRN, a rare neurodegenerative disease. It's the first investigational medicine for FTD-GRN, aiming to elevate progranulin levels. Currently in Phase 3 study, it addresses a significant unmet need with no FDA-approved treatments available.