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Alzamend Neuro Announces Positive Phase IIA Clinical Trial Results for AL001
Topline data identifies maximum tolerated dose from Phase IIA multiple ascending dose study as assessed by an independent safety review committee Identified
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nTopline data identifies maximum tolerated dose from Phase IIA multiple ascending dose study as assessed by an independent safety review committee\n\n\n\nIdentified dose is unlikely to require lithium therapeutic drug monitoring\n\n\n\nAlzamend plans two Phase II clinical trials to investigate the safety and efficacy of AL001 for patients with mild to moderate Alzheimer’s disease\n\n\n\nInvestigational new drug applications to be filed for AL001 for treatment of bipolar disorder, major depressive disorder and post-traumatic stress disorder\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 (“BPD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced that it has successfully identified a maximum tolerated dose (“MTD”) for development of AL001 from a multiple-ascending dose study as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily (“TID”), is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”). Also, this MTD is risk mitigated for the purpose of treating fragile populations, such as Alzheimer’s patients.\n\nLithium is a commonly prescribed drug for manic episodes in BPD type 1 as well as maintenance therapy of BPD in patients with a history of a manic episode. Lithium is also prescribed off-label for MDD, BPD and treatment of PTSD, among other disorders. Lithium was the first mood stabilizer approved by the United States Food and Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”) but is underutilized perhaps because of the need for TDM. Lithium was the first drug that required TDM by regulatory authorities in product labelling because the effective and safe range of therapeutic drug blood concentrations is narrow and well defined for treatment of BPD when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness.\n\nAL001 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 neurodegenerat...