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 we are working towards conducting a Phase II multiple-ascending doze study during the second quarter of 2022. 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 second 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.
AL001 – Alzheimer’s disease
AL001 – Bi-Polar disorder
AL001 – Depression
AL001 – Post Traumatic Stress Disorder (PTSD)
AL002 – Alzheimer’s disease
AL001 (aka LISPRO)
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 E22W)
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.