Alzamend Neuro has announced a partnership with Massachusetts General Hospital (Mass General) to conduct a Phase II clinical trial of its lithium therapeutic drug candidate, AL001, to treat patients with Alzheimer’s disease.
The trial will also include a cohort of healthy subjects to compare plasma and brain pharmacokinetics.
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Massachusetts General Hospital, affiliated with Harvard Medical School, will act as the contract research organisation for the study.
The trial aims to determine the comparative increase in lithium levels within the brain and its structures between Alzheimer’s patients and healthy subjects.
By analysing lithium content in patients’ brains during treatment, Alzamend aims to identify the minimum effective dose of AL001.
The company believes this study will support regulatory safety standards through the Section 505(b)(2) pathway for the US Food and Drug Administration (FDA) approval.
Alzamend has already completed a Phase IIA clinical trial, establishing a maximum tolerated dose for AL001.
This dose, equivalent to 240mg of lithium carbonate taken three times daily, is designed to be safe for fragile populations without requiring therapeutic drug monitoring.
Alzamend CEO Stephan Jackman said: “We are elated to partner with Mass General and Dr Andronesi in this pivotal study for our lead therapeutic candidate AL001.
“If we can develop a next-generation lithium product (AL001) with an improved safety profile and enhanced biodistribution in the brain that would not routinely require TDM, it would constitute a major improvement over current lithium-based treatments and positively impact the over six million Americans afflicted with Alzheimer’s. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”
