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Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Major Depressive Disorder Patients of its Next‑Generation Lithium Therapeutic Drug Candidate AL001
Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval Alzamend 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 a 505(b)(2) NDA pathway for FDA approval\n\n\n\n\nAlzamend recently completed a Phase IIA Study of AL001 in Alzheimer’s patients and healthy subjects showing a benign safety/ tolerability profile while characterizing dosing levels 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-MDD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for adjunctive treatment of patients with MDD.\n\n\nAlthough lithium does not have an FDA approved indication for augmentation of an antidepressant in MDD, it has been prescribed off-label for this purpose for decades. While a wide variety of medications have been used historically in this capacity, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials. Although the ideal role for lithium augmentation has yet to be established, there is evidence to support the clinical practice of adding lithium to conventional antidepressants in pursuit of MDD remission. Lithium augmentation has been cited as a strategy for depressed patients not responding to an antidepressant, lithium prophylaxis for recurrent unipolar depression as an alternative to prophylaxis with an antidepressant, and for lithium’s anti-suicidal properties, where appropriate.\n\n\nLithium 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 labelling 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 ...