ATLANTA– Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received the full data set from its Phase 1 clinical trial for AL001. The purpose of the Phase 1 first-in-human trial was to determine the pharmacokinetics, safety and tolerability of AL001. These data will help Alzamend establish doses for a planned Phase 2 multiple ascending dose study in Alzheimer’s disease (“Alzheimer’s”) patients. AL001 is a novel lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s. AL001 has the potential to deliver benefits of marketed lithium carbonate without current toxicities.
It is difficult to set the appropriate dose of lithium carbonate and other lithium products due to the small margin between effective and toxic blood levels and to avoid side effects or inadequate treatment outcomes. Studies in mice showed advantageous site-of-action (brain) penetration and persistence of lithium (Via AL001) compared to lithium carbonate, indicating the possibility of reducing the lithium dose needed for efficacy, which could reduce potential side effects and reduce or eliminate blood level monitoring requirements.
The full data set builds upon topline data previously reported on December 21, 2021. These 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.
During this Phase 1 trial, participants received a single dose of AL001 containing lithium in an amount equivalent to 150 mg lithium carbonate; at the dose proposed deemed appropriate for Alzheimer’s treatment when given three times daily. Currently, marketed lithium carbonate 300 mg are given three times daily when prescribed for manic episodes in bipolar disorder as well as maintenance therapy of bipolar disorder in patients with a history of manic episodes. Lithium is also prescribed off-label for major depression, often as an adjunct therapy, as well as for people with bipolar disorder without a history of mania, and treatment of post-traumatic stress disorder (“PTSD”).
“This is excellent news for the 3+ million Americans currently taking lithium-based treatments,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We see the possibility of providing the benefits from AL001 containing lithium at up to 50% of the currently approved lithium carbonate dosage, with the potential for better outcomes and elimination of the need for lithium therapeutic drug monitoring. Moreover, the data confirm AL001’s potential as a replacement of the current lithium-based treatment and may provide a treatment to the over 40+ million Americans suffering from Alzheimer’s, Bipolar disorder, Depression and PTSD.”
Based on the Phase 1 results, it has been shown that dose-normalized bioequivalence for lithium was established between AL001 and the marketed reference lithium carbonate 300 mg capsule. AL001 was shown to be safe and well-tolerated in healthy adult subjects. AL001 salicylate exposures were within safe limits. No clinically significant abnormal findings in electrocardiograms were noted during the trial. No serious adverse events and no deaths were reported during the trial.
Findings of plasma bioequivalence to a marketed lithium product may allow Alzamend to reduce the scope or eliminate the need for Phase 2 and 3 studies of efficacy and/or safety of AL001 in such indications as bipolar/affective disorders in which lithium efficacy has been established. Bioequivalence may have utility for AL001 when seeking approval for the indications of currently marketed lithium products, and for new indications as a benchmark for safety.
Mr. Jackman added, “We look forward to swiftly initiating a Phase 2 multiple ascending dose study involving Alzheimer’s patients in the second quarter of 2022. Additionally, we look forward to pursuing investigational new drug applications with the United States Food and Drug Administration during 2022 for bipolar disorder, depression, and PTSD indications, and given the major unfilled public health need in these indications, we intend to seek expedited regulatory interaction.”
