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Alzamend Neuro Announces Pre-IND Submission for AL001 as a Treatment of Bipolar Disorder, Major Depressive Disorder and Post-Traumatic Stress Disorder
Topline data expected in December 2022 from ongoing Phase IIA multiple ascending dose clinical trial for AL001 treatment of dementia related to Alzheimer’s
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nTopline data expected in December 2022 from ongoing Phase IIA multiple ascending dose clinical trial for AL001 treatment of dementia related to Alzheimer’s \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 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”).\n\nAL001 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.\n\n“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.”\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...