Business
Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients
Alzamend’s recently completed Phase IIA study of AL001 in Alzheimer’s patients and healthy subjects identified a candidate dose that is unlikely to require
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nAlzamend’s recently completed Phase IIA study of AL001 in Alzheimer’s patients and healthy subjects identified a candidate dose that is unlikely to require therapeutic drug monitoring\n\n\n\n\nSafety aspects of AL001 development may qualify for a Section (505)(b)(2) NDA pathway in support of FDA approval\n\n\n\n ATLANTA--(BUSINESS WIRE)--\nAlzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced receipt of a “Study May Proceed” letter from the U.S. Food and Drug Administration (“FDA”) for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD type 1.\n\n\n“We are grateful to receive this timely, favorable response from the FDA to initiate our first Phase IIA clinical study of AL001 for BD. Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option (considered the “gold standard”) for BD type 1,” said Stephan Jackman, Chief Executive Officer of Alzamend. “If we are able to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring (“TDM”), it would constitute a major improvement over current lithium-based treatments and positively impact the 7 million Americans afflicted with BD. We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”\n\n\nAbout AL001\n\n\nAL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified a maximum tolerated dose (“MTD”), as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts. This can serve to mitigate or obvi...