Next‑Generation Lithium Therapeutic Drug Candidate Study May Proceed

Alzamend Neuro, Inc. today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for the treatment of patients with major depressive disorder ("MDD"), also known simply as depression.

While a wide variety of medications have been used historically for augmentation of an antidepressant in MDD, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials.

AL001 is a novel lithium-delivery system that can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.

Alzamend's goal is to revive the utility of lithium treatment by significantly improving the benefit-to-risk relationship of lithium treatment in clinical practice.

Stephan Jackman, Chief Executive Officer of Alzamend, commented in a press release on November 20, 2023, “If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the 21 million Americans afflicted with MDD."

"We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”

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.

As of November 21, 2023, the FDA has not approved a vaccine candidate targeting depression of Alzheimer's disease.