Alzamend Neuro's AL001 Lithium Imaging Data Accepted for Oral Presentation at ISMRM X-Nuclei Workshop
核心洞察
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.
Alzamend Neuro, Inc. (Nasdaq: ALZN), a clinical-stage biopharmaceutical company focused on novel treatments for Alzheimer's disease (搜索), bipolar disorder type 1 (搜索) (BD), major depressive disorder (搜索) (MDD) and post-traumatic stress disorder (搜索) (PTSD), announced that an abstract reporting pharmacokinetic imaging data for AL001 has been accepted for oral presentation at the International Society for Magnetic Resonance in Medicine (ISMRM) Workshop on Beyond Protons: Challenges and Advances in X-Nuclei MR. The workshop will be held from September 28 – October 1, 2026 at the Universitat Oberta de Catalunya (UOC) in Barcelona, Spain.
The abstract, titled "Pharmacokinetics Imaging of Lithium at 7T – Results from a Phase 1/2A Clinical Trial with a Novel Organic Lithium Salt" (Abstract #00047), was selected following a competitive review by the workshop's organizing committee and will be presented in the "Proffered Papers" oral session on Tuesday, September 29, 2026 at 1:35 PM local time.
First-of-Its-Kind Pharmacokinetic Imaging
The 10-minute oral presentation will report pharmacokinetic imaging findings obtained at 7T from the completed Phase 1/2A clinical trial of AL001, Alzamend's patented ionic cocrystal formulation of lithium, in healthy human subjects. The data will be presented by Dr. Ovidiu C. Andronesi, who developed the underlying 7T MR imaging methodology and served as the study's principal investigator.
"7T imaging finally lets us see what blood levels alone never could: how lithium actually behaves in human brain tissue over time," said Dr. Andronesi, Director of Multinuclear MRI at the Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, and Associate Professor of Radiology at Harvard Medical School. "These pharmacokinetic data give us a much sharper picture of how AL001 reaches and persists in the brain."
Stephan Jackman, Chief Executive Officer of Alzamend, added: "An oral presentation at ISMRM's X-nuclei workshop is a strong indication that this data holds up to scientific scrutiny. Dr. Andronesi's imaging work shows us, non-invasively, how AL001 delivers lithium to the brain, evidence that speaks directly to the millions of patients worldwide who could benefit from a better-tolerated lithium therapy."
Study Design and Methodology
The study employed a randomized crossover design with multiple six-subject cohorts. Participants were assigned to one of two sequences: AB (AL001 then lithium carbonate) or BA (lithium carbonate then AL001). Each treatment period consisted of 14 days of three-times-daily dosing, separated by a 14-day washout.
On Days 14–15, participants underwent 24-hour pharmacokinetic blood sampling alongside advanced MRI and magnetic resonance spectroscopy (MRS) neuroimaging, a first-of-its-kind methodology. The MRI and MRS neuroimaging methods were developed by the lab of Dr. Andronesi. The study also incorporated a specialized, engineered head coil developed by Tesla Dynamic Coils BV, designed to enable high-resolution, whole-brain lithium imaging. This approach enabled simultaneous quantification of lithium concentrations in blood and brain, including individual structures, as well as assessment of brain and individual brain structure chemistry, metabolism, and biomarker effects.
The study specifically evaluated AL001's ability to enhance lithium delivery to targeted brain regions while reducing systemic exposure, an approach designed to address the long-standing safety and tolerability limitations associated with traditional lithium salts. The results confirmed that AL001 matches blood levels of standard lithium carbonate, the reference drug, addressing U.S. Food and Drug Administration regulatory requirements for a new drug formulation, as well as providing a differentiated, potential dose-sparing benefit profile for patients.
A Differentiated Lithium Therapy for a Large Unmet Need
Although lithium has remained the gold standard treatment for BD for more than 55 years, its clinical utility is constrained by a narrow therapeutic window and the need for regular therapeutic drug monitoring to manage renal, thyroid, and other systemic toxicity risks. AL001 is Alzamend's patented ionic cocrystal formulation of lithium combined for delivery with L-proline and salicylate, which is designed to deliver a full therapeutic amount of lithium to the brain with less systemic exposure than lithium carbonate, potentially enabling a safer, better-tolerated therapy across Alzheimer's, BD, MDD and PTSD.
The workshop is organized by ISMRM and the International Society for MR Radiographers & Technologists, bringing together researchers, clinicians and industry partners focused on non-proton, or "X-nuclei," magnetic resonance imaging. The program covers technical advances and clinical applications in imaging nuclei such as sodium, phosphorus, carbon and lithium, featuring invited talks, proffered oral papers and poster sessions.
Alzamend's pipeline consists of two novel therapeutic drug candidates: AL001, a patented ionic cocrystal delivering lithium with salicylate and L-proline designed to improve brain delivery and safety compared to conventional lithium, and ALZN002, a patented cell-based therapeutic vaccine designed to restore the immune system's ability to clear Alzheimer's beta-amyloid. Both candidates are exclusively licensed from the University of South Florida Research Foundation under royalty-bearing worldwide licenses.