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Alzamend Neuro Submits IND Application for Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Safety aspects of AL001 development may qualify for (505)(b)(2) pathway for FDA approval Alzamend’s recently completed a Phase IIA Study of AL001 in
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nSafety aspects of AL001 development may qualify for (505)(b)(2) pathway for FDA approval\n\n\n\n\nAlzamend’s recently completed a Phase IIA Study of AL001 in Alzheimer’s and healthy patients that identified a candidate dose that is unlikely to require therapeutic drug monitoring\n\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 submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD.\n\n\nLithium is a commonly prescribed drug for manic episodes in BD type 1 as well as maintenance therapy of BD in patients with a history of a manic episode. Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option (considered the “gold standard”) for BD but is underutilized perhaps because of the need for therapeutic drug monitoring (“TDM”). Lithium was the first drug that required TDM by regulatory authorities in product labeling because the effective and safe range of therapeutic drug blood concentrations is narrow and well defined for treatment of BD when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness.\n\n\nAL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s and healthy patients identified a maximum tolerated dose (“MTD”), as assessed by an independent safety review committee. This MTD, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily (“TID”), is designed to be unlikely to require TDM. Moreover, this dose is designed to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts and thereby avoiding clinical disadvantages.\n\n\nOnce the IND is c...