Less toxic lithium treatment for major depressive disorder set for phase 2a study

Key takeaways:

• AL001 by Alzamend Neuro will undergo a phase 2a trial in patients with major depressive disorder.
• The next-generation lithium delivery system favorably distributes to the brain, reducing toxicity.

A potential next-generation lithium treatment is set to be tested in major depressive disorder after the FDA issued a “study may proceed” letter for a phase 2a trial of AL001 by Alzamend Neuro.

“Although lithium does not have an FDA-approved indication for augmentation of an antidepressant in MDD, it has been prescribed off-label for this purpose for decades,” said Stephan Jackman, MS, CEO of Alzamend, said in a press release. “If we can develop a next-generation lithium product 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.”

Alzamend described AL001 as a novel lithium delivery system that can avoid toxicities of lithium salts by favorably distributing to the brain, leaving other organs less exposed. The company said it aims to “revive the utility” of lithium in clinical practice by improving its risk-benefit ratio.

The FDA’s green light for this trial comes after issuing a “study may proceed” letter for another study of AL001 in bipolar disorder type 1 and follows the identification of a maximum tolerated dose unlikely to require therapeutic drug monitoring.

AL001 may qualify for FDA approval under a pathway for new formulations of an available drug based on its “favorable” safety profile and “extensive safety data” on its constituent components, according to the release.