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Alzamend Neuro Announces Full Data Set From Phase 1 First-in-Human Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s
Data confirm the positive topline results announced in December 2021 demonstrating AL001 in plasma is bioequivalent to the marketed lithium carbonate product
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nData confirm the positive topline results announced in December 2021 demonstrating AL001 in plasma is bioequivalent to the marketed lithium carbonate product\n\n\nResults show that the shapes of the lithium plasma concentration versus time curves are similar to marketed product\n\n\n ATLANTA--(BUSINESS WIRE)--\nAlzamend 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.\n\nIt 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.\n\nThe 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 lithi...