Product Pipeline
Alzamend Neuro® is currently working to transition two therapeutics targeting Alzheimer’s disease (“AD”), Bipolar Disorder, Major Depressive Disorder (“MDD”) and post-traumatic stress disorder (“PTSD”) 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 AD, bipolar disorder, MDD, and PTSD. AL001 recently completed the clinical portion of Phase IIA trials and announced topline data in June 2023. Our second candidate, ALZN002, 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 AD. In October 2022 we received a “Study May Proceed” letter from the U.S. Food and Drug Administration (“FDA”) for a phase I/IIA clinical trial under its Investigational New Drug (“IND”) application for an immunotherapy (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type. We initiated the trial in March 2023. There are no profound treatments today for AD, bipolar disorder, MDD and PTSD. With AL001 and ALZN002, the Company believes that we can change that.
Current Pipeline
AL001 – Alzheimer’s disease
AL001 – Bipolar Disorder*
AL001 – Major Depressive Disorder*
AL001 – Post Traumatic Stress Disorder (PTSD)*
ALZN002 – Alzheimer’s Disease
*Anticipate initiating a Phase II clinical study in 2025
AL001 (aka LISPRO®)
Our most advanced product candidate (lead product) AL001 is licensed and in clinical development in humans is an ionic cocrystal of lithium for the treatment of Alzheimer’s Disease (“Alzheimer’s), Bipolar Disorder, Major Depressive Disorder (“MDD”) and post-traumatic stress disorder (“PTSD”). Based on our preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and is superior in improving associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD in humans.
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 dose study in Alzheimer’s patients and completed the clinical portion of the trial in March 2023. Topline data expected in June 2023. In the second half of 2023 we received “Study May Proceed” notifications from the U.S. Food and Drug Administration (the “FDA”) regarding our indications for Bipolar Disorder, Major Depressive Disorder, and Post-traumatic Stress Disorder. We anticipate initiating Phase II clinical studies in 2025.
Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden for safety data. 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. 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.
ALZN002 (aka E22W)
ALZN002, 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 ALZN002 is through the pulsed-Dendritic Cell (“DC”) activation of T-cells that stimulates the immune system, resulting in the clearance of brain amyloid. In October 2022 we received a “Study May Proceed” letter from the U.S. Food and Drug Administration (“FDA”) for a phase I/IIA clinical trial under its Investigational New Drug (“IND”) application for an immunotherapy (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type. We initiated the Phase I/IIA clinical trial in March 2023.
ALZN002 is based on the theory that Alzheimer’s symptoms may be caused in large part by plaque deposits that can cluster in the brain composed of protein fragments called beta-amyloids that build up between nerve cells. One hypothesis is that a special type of immune cell, natural beta-amyloid antibodies, may play a role in preventing plaque build-up in people without Alzheimer’s. As people age, their immune systems may degrade, and some people may be unable to produce natural beta-amyloid antibodies, the absence of which leads to the plaque build-up causing Alzheimer’s. ALZN002 is intended to elicit an immune response to produce anti-amyloid antibodies, which can then neutralize circulated beta-amyloids and prevent additional plaque build-up. The mutant antigen within ALZN002 was selected specifically for its high HLA binding affinity, thereby avoiding the need for an adjuvant, which may cause an adverse (Th1) immune response. ALZN002 is an autologous modified DC treatment. More precisely, it is a patient-specific therapy where the patient undergoes leukapheresis, a nonsurgical treatment used to reduce the quantity of white blood cells in the bloodstream, to isolate peripheral blood monocytes that are subsequently matured into DCs using an IL4+ GM-CSF cocktail. The DCs are incubated with a modified amyloid beta (Aβ) peptide (“ALZN002 peptide”) to sensitize them, and then administered to the same patient.
