Benzinga | Dec 17, 2021 09:01AM EST

Alzamend Neuro Announces Topline Data From Phase 1 First-in-Human Clinical Trial For AL001 Treatment Of Dementia Related To Alzheimer's; Data showed AL001 Is 'bioequivalent to the marketed lithium carbonate product'

Data shows that AL001 is bioequivalent to the marketed lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar

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 positive topline data from its Phase 1 clinical trial for AL001. The purpose of the Phase 1 first-in-human study was to determine the pharmacokinetics, safety and tolerability of AL001 so as to target doses for a planned Phase 2 multiple ascending dose study in Alzheimer's patients. AL001 is a lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic co-crystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer's disease.

During this Phase 1 first-in-human trial, participants received a single dose of AL001 containing lithium in an amount equivalent to 150 mg lithium carbonate; this is the dose proposed by the inventors as likely appropriate for Alzheimer's treatment when given three times daily. Currently, marketed immediate-release lithium carbonate 300 mg are given three times daily; for example, lithium carbonate 300 mg three times daily is a dose commonly used for bipolar affective disorders. It can be 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.

"This is amazing news," said Stephan Jackman, Chief Executive Officer of Alzamend. "We see the possibility of providing the benefits from lithium at up to 50% of the currently approved lithium carbonate dosage, with the potential for better outcomes and with elimination of the need for lithium therapeutic drug monitoring. Moreover, the data confirms AL001's potential as a replacement of the current lithium-based treatments and may provide a treatment to the over 40 million Americans suffering from Alzheimer's and other neurodegenerative diseases and psychiatric disorders."

Dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption indicate that AL001 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.

Such findings may allow the Company to reduce or eliminate the need for Phase 2 and Phase 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. Given the systemic pharmacokinetic similarity to marketed immediate-release lithium carbonate products, AL001 may be dosed three times daily in the planned Phase 2 study, a multiple ascending dose safety study in Alzheimer's patients.

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 post-traumatic stress disorder indication, and given the major unfilled public health need in these indications, we intend to seek expedited regulatory interaction."