ATLANTA– Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has submitted a Pre-IND (investigational new drug) meeting request for AL001 and supporting briefing documents to the U.S. Food and Drug Administration (“FDA”) for the treatment of bipolar disorder, major depressive disorder and post-traumatic stress disorder (“PTSD”).
AL001 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 dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s disease (“Alzheimer’s”). AL001 has the potential to deliver benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium. In a Phase I relative bioavailability comparison of AL001 to lithium carbonate completed in March 2022, AL001 was shown to provide dose-normalized bioequivalent plasma pharmacokinetics and the observed safety profile was benign. A phase IIA, Multiple Ascending Dose (“MAD”) clinical trial for the treatment of dementia related to Alzheimer’s is currently underway.
“We are excited about pursuing three additional indications for AL001,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are one step closer to showing that AL001 can potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million Americans suffering from Alzheimer’s and other neurodegenerative diseases and psychiatric disorders. We look forward to receiving FDA feedback and advice regarding the appropriateness and acceptability of the proposed development program and clinical plan.”
Lithium 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 a manic episode. The primary target symptoms of lithium are mania and unstable mood. Lithium is also prescribed off-label for major depressive disorder (often as an adjunct therapy), bipolar disorder (without a history of mania), and treatment of PTSD, among other neurodegenerative, neurological and neuropsychiatric disorders.
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 bipolar disorder when using lithium salts. Excursions above this range can be toxic. AL001 may enhance lithium distribution into target tissues in the central nervous system (brain) but at lower systemic exposures, resulting in an improved safety profile compared to lithium salts, including the possibility of mitigating lithium side effects and the current requirement for TDM.
