Next-generation lithium treatment for bipolar disorder to be studied

Key takeaways:

• AL001 is designed to target lithium delivery in the brain, mitigating toxicity in other organs.
• The drug will be studied as a safer lithium treatment for bipolar disorder type 1.

A potential new lithium treatment for bipolar disorder, designed to avoid toxicities currently associated with the substance, is set to undergo a phase 2 study.

The FDA has issued a “study may proceed” letter for a phase 2a clinical trial of AL001 in bipolar disorder type 1, according to a press release from Alzamend Neuro Inc. The release said the drug is designed to deliver lithium in a way that focuses on the brain and lessens exposure to other body organs.

“If we are able to 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,” Alzamend CEO Stephan Jackman, MS, said. “We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”

In the release, Alzamend described AL001 as “a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate.” The company said its goal is to “revive the utility of lithium treatment” by reducing its risks.

The FDA’s green light for this trial comes after topline data from a study of AL001 in Alzheimer’s disease identified 240 mg, three times daily, as a maximum tolerated dose unlikely to require therapeutic drug monitoring.

AL001 “may qualify” for FDA approval through a pathway that applies to new formulations of approved drugs, the release stated, citing the favorable safety profile observed in the Alzheimer’s study and “extensive safety data on the drug’s constituent components.”