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Alzamend Neuro Announces Positive Topline Data from Phase 1 First-in-Human Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s
Data shows that AL001 is bioequivalent to the marketed lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\nData shows that AL001 is bioequivalent to the marketed lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar\n\n TAMPA, Fla.--(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 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.\n\nDuring 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.\n\n“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.”\n\nDose-adjusted relative bioavailability analyses of the rate and extent of lith...