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Alzamend Neuro Announces Initiation of Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s
Topline data expected in December 2022 Full data from Phase I first-in-human study demonstrated AL001 in plasma is bioequivalent to the marketed lithium
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nTopline data expected in December 2022\n\n\nFull data from Phase I first-in-human study demonstrated AL001 in plasma is bioequivalent to the marketed lithium carbonate 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 the first patient with mild to moderate Alzheimer’s disease (“Alzheimer’s”) has been dosed in a 12-month Phase IIA multiple ascending dose (“MAD”) study for dementia related to Alzheimer’s. The MAD study is for the purpose of evaluating the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determining the maximum tolerated dose in patients diagnosed with mild to moderate Alzheimer’s. 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 while mitigating or avoiding current toxicities associated with lithium.\n\n“Advancing AL001 into a Phase IIA clinical trial as planned marks an important milestone for Alzamend,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are one step closer to proving that AL001 could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million Americans suffering from Alzheimer’s and other neurodegenerative diseases and psychiatric disorders. We look forward to completing the MAD study and further advancing clinical development of this promising potential therapeutic.”\n\nAbout AL001 Phase IIA Study\n\nThe Phase IIA study will evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose in patients diagnosed with mild to moderate Alzheimer’s. Lithium has been well characterized for safety and is approved/marketed in multiple formulations for bipolar affective disorders. Lithium dosing for the MAD cohorts is based on a fraction of the usual dose for treatment of bipolar affective disorder (i...