US-based biopharma company Alzamend Neuro has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the initiation of a Phase IIa trial with its AL001 candidate for bipolar disorder treatment.

The company is exploring the use of its patented ionic cocrystal technology, which delivers lithium via a therapeutic combination of lithium, proline and salicylate.

Lithium is considered the gold-standard treatment for bipolar disorder, but Alzamend says that it is potentially underutilised because of the need for therapeutic drug monitoring due to the treatment’s narrow operating window.

Licensed from the University of South Florida Research Foundation, Alzamend’s lithium-delivery system aims to overcome currently experienced toxicities associated with lithium. The company has already identified a maximum tolerated dose via a recently completed multiple ascending dose Phase IIa study in patients with Alzheimer’s disease. The dose, which is 240mg three times a day, is unlikely to require therapeutic drug monitoring and also helps distribute more lithium to the brain, Alzamend claims.

If approved by the FDA, Alzamend will use the upcoming Phase IIa study to observe the relatively increased levels of lithium in the brain when treated with AL001 compared to marketed lithium salt. The company plans to use its system to deliver 20% less lithium daily to patients.

Alzamend’s CEO Stephan Jackman said: “This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline.”

“Being able to develop a next-generation lithium product (AL001) that would not routinely require TDM could positively impact the seven million Americans afflicted with BD. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”