Alzamend Neuro, Inc. is a clinical-stage biopharmaceutical company, which focuses on developing various products for the treatment of neurodegenerative and psychiatric disorders. The company's pipeline includes AL001, which is in Phase II clinical trial, and delivers a therapeutic combination of lithium, proline, and salicylate for the treatment of Alzheimer's, bipolar disorder, post-traumatic stress disorder, major depressive disorder, other neurodegenerative diseases, and psychiatric disorders, and AL002, which completed preclinical stage, and uses a method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine to restore the ability of a patient's immunological system to combat Alzheimer's disease. The company was founded on February 26, 2016 by Milton C. Ault, III and is headquartered in Atlanta, GA.
Clinical Trials
4
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2016
Active, not recruiting
1
25.0%
Completed
2
50.0%
Recruiting
1
25.0%
No approval data available
- Alzamend Neuro announced that pharmacokinetic imaging data for AL001, its novel organic lithium salt, has been accepted for oral presentation at the ISMRM Workshop on Beyond Protons in Barcelona, Spain. - The abstract reports first-of-its-kind 7T imaging results from a completed Phase 1/2A trial showing how AL001 delivers and persists lithium in human brain tissue. - The study confirmed AL001 matches blood levels of standard lithium carbonate while providing a differentiated, potential dose-sparing benefit profile for patients. - AL001 is designed to deliver a full therapeutic amount of lithium to the brain with less systemic exposure, potentially enabling a safer therapy across Alzheimer's, bipolar disorder, MDD and PTSD.
- Alzamend Neuro has completed the clinical portion of its Phase II study of AL001, a novel lithium-delivery system designed to improve brain penetration while reducing systemic side effects. - The study utilized advanced brain imaging technology to compare AL001's lithium distribution versus conventional lithium carbonate in healthy subjects at Massachusetts General Hospital. - AL001 aims to eliminate the need for therapeutic drug monitoring by achieving superior brain uptake with lower blood lithium levels, potentially transforming treatment for neuropsychiatric disorders. - Topline data is expected in the first quarter of 2026, with Phase II trials in Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD planned for next year.
- Alzamend Neuro completed a $5 million private placement months ahead of schedule to fund five Phase II clinical trials of AL001 "Lithium in Brain" studies at Massachusetts General Hospital. - The company's AL001 drug candidate uses patented ionic cocrystal technology to deliver lithium via a therapeutic combination of lithium, salicylate and L-proline for treating neurological and psychiatric conditions. - Five Phase II trials are planned across multiple indications, with the first healthy subject trial initiated in May 2025 and additional trials for bipolar disorder, Alzheimer's disease, major depressive disorder and PTSD expected to commence through Q4 2025. - The financing targets treatment solutions for over 43 million Americans afflicted with Alzheimer's disease, bipolar disorder, major depressive disorder and post-traumatic stress disorder.
- Alzamend Neuro partners with Tesla Dynamic Coils BV to develop a groundbreaking MRI head coil for measuring brain lithium levels across five Phase II clinical trials at Massachusetts General Hospital. - The specialized coil will enable high-resolution whole-brain lithium imaging to compare AL001's performance against standard lithium carbonate in treating Alzheimer's disease, bipolar disorder, depression, and PTSD. - Initial mouse studies suggest AL001 achieves optimal brain absorption with lower blood concentrations than lithium carbonate, potentially eliminating the need for therapeutic drug monitoring.
- Alzamend Neuro will present at the Sequire Investor Summit on January 22, 2025, to update on clinical trial progress. - CEO Stephan Jackman will highlight the company's improved financial position and AL001's Phase II trials. - Five Phase II trials for AL001, in partnership with Massachusetts General Hospital, are set to begin in 2025. - Alzamend is focused on developing treatments for Alzheimer’s, bipolar disorder, major depressive disorder, and PTSD.
- Alzamend Neuro reported a significant financial turnaround, with net cash from financing activities reaching $8.3 million for the six months ended October 31, 2024. - The company's stockholder equity improved to $3.8 million, and cash reserves increased to $4.1 million, bolstering its balance sheet. - Alzamend is set to initiate five Phase II clinical trials in 2025 for AL001, a novel lithium therapy, targeting Alzheimer's, bipolar disorder, major depression, and PTSD. - The company also plans to resume trials for ALZN002, an immunotherapy for Alzheimer's disease, after engaging a new clinical research organization.
- Alzamend Neuro has established the maximum tolerated dosage for AL001, a novel lithium therapy, intended for use in upcoming clinical trials for Alzheimer's disease and related disorders. - The determined dosage of AL001 is unlikely to necessitate intensive therapeutic drug monitoring, potentially improving patient care and adherence compared to traditional lithium formulations. - Phase 1/2 clinical trial data demonstrated that AL001 was generally well-tolerated, exhibiting a benign safety profile across various dosage levels in both healthy volunteers and Alzheimer's patients. - Alzamend Neuro is collaborating with Massachusetts General Hospital to further evaluate AL001 in Phase 2 trials across multiple conditions, including Alzheimer's, bipolar disorder, major depressive disorder, and PTSD.
- Alzamend Neuro (ALZN) has regained compliance with Nasdaq's minimum stockholders' equity requirement of $2.5 million, avoiding potential delisting. - A $25 million securities purchase agreement for Series A Convertible Preferred Stock has been secured, providing financial stability. - The company plans to initiate five Phase II clinical trials of AL001 in 2025, in partnership with Massachusetts General Hospital. - Alzamend is focused on developing treatments for Alzheimer’s, bipolar disorder, major depressive disorder, and PTSD.
- Alzamend Neuro partners with Massachusetts General Hospital to conduct a Phase II clinical trial of AL001 for bipolar disorder. - The trial will compare AL001 head-to-head against a marketed lithium carbonate product to optimize dosing. - The goal is to identify a safe and effective dose of AL001 by assessing lithium levels in the brain. - AL001 is a novel lithium-delivery system designed to improve safety and brain bioavailability compared to existing lithium salts.
- Alzamend Neuro is collaborating with Massachusetts General Hospital to advance AL001, a novel lithium-delivery system, into a Phase 2 clinical trial for Alzheimer's disease. - The trial aims to compare brain levels of AL001 with those of marketed lithium, seeking to determine the minimum effective dose and evaluate the therapy’s safety profile. - AL001 is designed to deliver lithium specifically to the brain, potentially reducing exposure to other organs and minimizing side effects compared to current lithium treatments. - Previous Phase 1/2 trial data suggest AL001 was generally well-tolerated and achieved similar lithium blood levels at lower doses than marketed lithium.
