Alzamend Neuro, Inc. announced receipt of a ?Study May Proceed? letter from the U.S. Food and Drug Administration for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD type 1. AL001 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, 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 obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers.

Lithium is a chemical entity well known for efficacy in BD type 1. Alzamend?s goal is to revive the utility of lithium treatment by importantly improving the benefit-to-risk relationship of lithium treatment in clinical practice. Based on the favorable AL001 safety profile observed in the recently completed study and extensive safety data on the drug?s constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application pathway for FDA approval, which is available to new formulations of an approved drug.