Next-Generation Lithium Therapeutic Drug Candidate in Bipolar Disorder Proceeds to Phase IIA

Without an approved Alzheimer's disease vaccine available, several bipolar disorder (BD) candidates are following U.S. Food and Drug Administration (FDA) policies to accelerate clinical research.

In the U.S., about 2.8% of the population is estimated to be affected by BD during the past year, says the U.S. NIH.

For example, Alzamend Neuro, Inc. today announced receipt of a “Study May Proceed” letter from the U.S. FDA 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, 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. 

“Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option for BD type 1,” said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on Octobe 2, 2023.

“If we are able to 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 seven 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"

Based on the favorable 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.

BD is a mood disorder characterized by periods of depression and periods of abnormally elevated happiness.

The condition is classified as BD Type 1 if there has been at least one manic episode, with or without depressive episodes.

And can be classified as BD Type 2 if there has been at least one hypomanic episode (but no full manic episodes) and one major depressive episode.

As of October 2023, there are several Alzheimer's disease vaccines and therapies conducting clinical trials which are seeking participants.