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Alzamend Neuro Announces Full Data Set from Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s
Data confirm the positive topline results announced in June 2023 identifying a maximum tolerated dose as assessed by an independent safety review committee
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nData confirm the positive topline results announced in June 2023 identifying a maximum tolerated dose as assessed by an independent safety review committee\n\n\nIdentified dose is unlikely to require lithium therapeutic drug monitoring\n\n\nData will guide upcoming “Lithium in Brain” Phase II clinical trials in partnership with Massachusetts General Hospital, which were announced in August 2024\n\n\n ATLANTA--(BUSINESS WIRE)--\nAlzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced that it has received the final full data set from its multiple ascending dose clinical trial for AL001 treatment of dementia related to Alzheimer’s.\n\nBuilding on the promising preliminary results released in June 2023, Alzamend’s full data set confirms the successful determination of a maximum tolerated dose (“MTD”) for AL001. Identified by an independent safety review committee, this MTD represents a pivotal step forward; it delivers lithium at a lithium carbonate equivalent dose of 240 mg, taken three times daily (“TID”). This is an AL001 formulation that will unlikely require the need for traditional lithium therapeutic drug monitoring (“TDM”). This innovation is specifically designed to address the needs of fragile populations, such as elderly and Alzheimer’s patients, by offering a potentially more efficient and safer alternative to existing treatments.\n\nLithium, renowned for its efficacy as a first-line therapy for manic episodes and maintenance in bipolar disorder, has long been underutilized due to the complexities of TDM. Current U.S. Food and Drug Administration-approved lithium salts (carbonate and citrate) are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations. Existing lithium drugs suffer from chronic toxicity, poor physicochemical properties, and poor brain bioavailability. Alzamend’s novel AL001 formulation,...