ATLANTA– Alzamend 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.
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 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.
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.
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. Alzamend plans to conduct further studies designed to enable it to ascertain comparative brain penetration and persistence of AL001 to lithium carbonate. These studies are expected to help predict observations seen in pharmacokinetic nonclinical findings to improve treatments in humans, including the potential for AL001 to exhibit lithium dose sparing properties that could mitigate lithium side effects and the current requirement for TDM in blood. 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. Since providing a greater concentration of lithium to the brain while minimizing the amount of the drug delivered to other organs can improve overall safety, AL001 has the potential to provide a safer product compared to currently marketed lithium salts.
“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,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are one step closer to substantiating 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, bipolar disorder, MDD, and PTSD. We appreciate the FDA’s recommendations, guidance, and other helpful advice. We plan to enhance our proposed clinical trial protocols and proceed accordingly.”
Based on the FDA’s written feedback, Alzamend anticipates filing the INDs for bipolar disorder, MDD and PTSD upon the completion of the current Phase IIA MAD study. This will allow Alzamend to initiate Phase II clinical trials for all three new indications.
