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.

AL001 – Alzheimer’s disease

  1. PRE-CLINICAL
  2. IND ENABLING
  3. PHASE 1
  4. PHASE 2
  5. PHASE 3

AL001 – Bi-Polar disorder

  1. PRE-CLINICAL
  2. IND ENABLING
  3. PHASE 1
  4. PHASE 2
  5. PHASE 3

AL001 – Major Depressive Disorder

  1. PRE-CLINICAL
  2. IND ENABLING
  3. PHASE 1
  4. PHASE 2
  5. PHASE 3

AL001 – Post Traumatic Stress Disorder (PTSD)

  1. PRE-CLINICAL
  2. IND ENABLING
  3. PHASE 1
  4. PHASE 2
  5. PHASE 3

AL002 – Alzheimer’s disease

  1. PRE-CLINICAL
  2. IND ENABLING
  3. PHASE 1
  4. PHASE 2
  5. PHASE 3
* Awaiting results from a Phase IIA Multiple Ascending Dose/ Tolerability Alzheimer’s Patient Study to Submit IND to Initiate a Phase II Trial

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. In July 2022 we received written response from the U.S. Food and Drug Administration (the “FDA”) regarding our meeting request relating to its Type B Pre-Investigational New Drug (“IND”) application. The FDA’s response provides a path for Alzamend’s planned clinical development of AL001 for the treatment of Bipolar Disorder, MDD and PTSD.

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.

AL002 (aka E22W)

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.

AL002 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. AL002 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 AL002 was selected specifically for its high HLA binding affinity, thereby avoiding the need for an adjuvant, which may cause an adverse (Th1) immune response. AL002 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 (“AL002 peptide”) to sensitize them, and then administered to the same patient.

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