Alzamend Neuro, Inc. (Nasdaq:ALZN) is 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”), announced today that it has received a written response to its meeting request related to its Type B Pre-Investigational New Drug (“IND”) Alzamend’s planned clinical development of AL001 for the treatment of bipolar disorder, MDD, and PTSD is enabled by the FDA’s response. AL001 is a novel lithium-delivery system; particularly, it is an engineered lithium-salicylate-L-proline ionic mendcocrystal being developed as an oral treatment for Alzheimer’s-related mild, moderate, and severe cognitive impairment dementia. AL001 has the potential to provide the advantages of commercially available lithium.
Lithium was the first mood stabilizer and remains a first-line therapy choice; nevertheless, it is underutilized, possibly due to the necessity for therapeutic drug monitoring (“TDM”) to ensure safe and effective blood concentrations and the availability of other medications. Lithium is a regularly recommended medication for manic episodes associated with bipolar illness, as well as for the maintenance treatment of bipolar disorder in patients with a history of manic episodes. Mania and mood fluctuations are the key symptoms of bipolar illness that are treated. Among other neurodegenerative, neurological, and neuropsychiatric problems, lithium is also prescribed off-label to treat MDD (typically as an additional therapy), bipolar disorder (without a history of mania), and PTSD.
Lithium was the first medicine to need TDM in product labeling because the effective and safe range of therapeutic drug blood concentrations for the treatment of bipolar disorder with lithium salts is narrow and well-defined. Exceeding this range can be hazardous. AL001 may increase lithium distribution into target tissues in the central nervous system (brain) but at lower systemic exposures, resulting in an enhanced safety profile compared to lithium salts, including the potential for reducing lithium side effects and the current need for TDM.
“We appreciate the thorough and meaningful response from the FDA, which provides us with the information and clarity needed to submit IND applications to initiate clinical trials for AL001 for the treatment of bipolar disorder, MDD, and PTSD,” stated Stephan Jackman, CEO of Alzamend (Nasdaq:ALZN).
He added that Over 40 million Americans suffer from Alzheimer’s, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. We are one step closer to proving that AL001 could give doctors a significant improvement over current lithium-based therapy. We value the FDA’s suggestions, guidelines, and other helpful information. We want to improve our suggested protocols for clinical trials and will proceed accordingly.
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