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Alzamend Neuro Receives Positive Pre-IND Response from FDA for AL001 Treatment of Bipolar Disorder, Major Depressive Disorder and Post-Traumatic Stress Disorder
Topline data expected in December 2022 from Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s Full data
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nTopline data expected in December 2022 from Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s\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 Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced that it has received a written response to its meeting request relating to its Type B Pre-Investigational New Drug (“IND”) application from the U.S. Food and Drug Administration (the “FDA”). The FDA’s response provides a path for Alzamend’s planned clinical development of AL001 for the treatment of bipolar disorder, MDD and PTSD. AL001 is a novel lithium-delivery system; specifically, it is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with dementia resulting from mild, moderate or severe cognitive impairment caused by Alzheimer’s. AL001 has the potential to deliver benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium.\n\nLithium was the first mood stabilizer and is still a first-line treatment option, but is underutilized, perhaps because of the need for therapeutic drug monitoring (“TDM”) to assure safe and effective blood concentrations, and the availability of newer treatments. Lithium is a commonly prescribed drug for manic episodes in bipolar disorder as well as maintenance therapy of bipolar disorder in patients with a history of manic episodes. The primary target symptoms of bipolar disorder are mania and mood swings. Lithium is also prescribed off-label for MDD (often as an adjunct therapy), bipolar disorder (without a history of mania), and treatment of PTSD, among other neurodegenerative, neurological and neuropsychiatric disorders.\n\nLithium 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 bipolar disorder when using lithiu...