Product Pipeline
Alzamend Neuro™ is currently working to transition two therapeutics targeting Alzheimer’s disease (“AD”) and psychiatric disorders from clinical/non-clinical stages and towards full commercialization. Our lead candidate, AL001, is a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate, for the treatment of Alzheimer’s and other neurodegenerative diseases and psychiatric disorders. On September 11, 2021, a first-in-human Phase I six-month clinical trial for AL001 commenced with the first patients dosed. Topline data for AL001 was reported on December 17, 2021, and the full data set was released in March 2022. The data affirmed that dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption in plasma indicate that AL001 at 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar. AL001 salicylate plasma concentrations were observed to be well-tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign. In May 2022 we initiated our Phase II multiple-ascending doze study in Alzheimer’s patients. Our second candidate, AL002, is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine which seeks to restore the ability of the patient’s immunological system to combat Alzheimer’s. The proposed mechanism of action of AL002 is through the pulsed-Dendritic Cell (“DC”) activation of T-cells that stimulates the immune system, resulting in the clearance of brain amyloid. On September 30, 2021, we announced that we received a written response from the FDA to our meeting request relating to our Type B Pre Investigational New Drug (“IND”) application pursuing a combined Phase I/Phase II study as a path for our planned clinical development of AL002. We plan on submitting an IND during the third quarter of 2022. There are no profound treatments today for Alzheimer’s disease and psychiatric disorders. With AL001 and AL002, the Company believes that we can change that.
Current Pipeline
AL001 – Alzheimer’s disease
Pre-Clinical
IND-Labeling
Phase 1
Phase 2
Phase 3
AL001 – Bi-Polar Disorder
Pre-Clinical
IND-Labeling
Phase 1
Phase 2
Phase 3
AL001 – Major Depressive Disorder
Pre-Clinical
IND-Labeling
Phase 1
Phase 2
Phase 3
AL001 – Post Traumatic Stress Disorder (PTSD)
Pre-Clinical
IND-Labeling
Phase 1
Phase 2
Phase 3
AL002 – Alzheimer’s Disease
Pre-Clinical
IND-Labeling
Phase 1
Phase 2
Phase 3
AL001 (aka LiProSal®)
AL001 is an ionic cocrystal of lithium and has been shown to exhibit improved nonclinical pharmacokinetics compared to current FDA-approved lithium products; it is also bioactive in many in vitro models of Alzheimer’s Disease. AL001 is expected to provide clinicians with a major improvement over current lithium-based treatments and may also constitute a means of treating Alzheimer’s and psychiatric disorders. Based on nonclinical data, AL001 cocrystal technology has the potential to improve the therapeutic index of lithium providing a greater bioavailability to the site of action (brain) in comparison to more traditional lithium dosage forms. Recent evidence suggests that lithium may be efficacious for both the treatment and prevention of Alzheimer’s. Unlike traditional medications which only address a single therapeutic target, lithium appears to be neuroprotective through several modes of action. For example, it exerts neuroprotective effects, in part, by increasing a brain-derived neurotrophic factor leading to restoration of learning and memory. Another neuroprotective mechanism of lithium is attenuation of the production of inflammatory cytokines like IL-6 and nitric oxide in activated microglia. Results from recent clinical studies suggest that lithium treatment may reduce dementia development while preserving cognitive function and reducing biomarkers associated with Alzheimer’s disease.
AL002 (aka CAO22W)
AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that reduces beta-amyloid plaque and seeks to restore the ability of the patient’s immunological system to combat Alzheimer’s disease. This therapy is intended to work by stimulating the body’s own immune system to prevent the formation and breakdown of beta amyloids, which build up in the brain to form a “plaque,” and subsequently block the neurological brain signals, ultimately leading to the symptoms and onset of Alzheimer’s. Immunotherapy is the treatment of disease by inducing, enhancing, or suppressing an immune response. We believe that strategies to strengthen the immune system in the elderly, who are most susceptible to the development of Alzheimer’s, could greatly enhance the effectiveness of immune-based approaches against Alzheimer’s. Our novel immune-based methodology attempts to inhibit the natural process of immunological aging by restoring the balance of the immune system through immunomodulation. Significant evidence has accumulated recently suggesting that immunotherapy is a highly promising modality of treatment in Alzheimer’s. Moreover, multiple preclinical studies and more than ten years of research have been conducted in preparation for this application.