Alzamend Neuro has announced that it will initiate a Phase II clinical trial for AL001, its novel lithium delivery system, aimed at treating bipolar disorder (BD). The trial is set to commence in the third quarter of 2025, marking a significant step in the development of advanced treatment options for BD patients.
The trial, to be conducted at Massachusetts General Hospital, will pit AL001 against a marketed lithium carbonate product. The objective is to compare lithium blood levels and brain pharmacokinetics in patients. Preclinical studies have shown promising results, suggesting that AL001 enhances brain absorption while maintaining lower blood lithium levels, potentially reducing systemic side effects.
Alzamend Neuro CEO Stephan Jackman has highlighted the potential of AL001 to transform BD care by improving safety and brain targeting without the need for therapeutic drug monitoring. The company aims to provide a more user-friendly and effective treatment path, facilitating better patient outcomes and quality of life.