Alzamend identifies maximum tolerated dose of lithium treatment for neurological disorders

Topline data from a phase 2a, multiple ascending dose study identified a maximum tolerated dose for development of AL001, an investigational lithium-delivery system, according to a press release from manufacturer Alzamend Neuro.

AL001 is a lithium-salicylate-L-proline engineered ionic cocrystal being developed as an oral treatment for patients with neurodegenerative, neurological and neuropsychiatric conditions such as Alzheimer’s disease, bipolar disorder, major depressive disorder and PTSD. The product has the potential to provide the benefits of currently marketed lithium salts without toxicities often associated with the drug, the company stated.

According to the release, the phase 2a study assessed the safety and tolerability of AL001 under multiple ascending dose conditions in patients with mild to moderate AD as well as healthy participants. An independent safety review committee identified a maximum tolerated dose that provides lithium at a lithium carbonate-equivalent dose of 240 mg three times daily and is unlikely to require lithium therapeutic drug monitoring. The dose is risk mitigated for the purpose of treating fragile populations, including patients with AD.

“The data support AL001 safety and tolerability and the potential for AL001 to provide a next-generation lithium therapy that does not require [therapeutic drug monitoring],” Stephan Jackman, Alzamend CEO, said in the release. “This can positively impact patient health and safety.

“We look forward to further evaluating AL001 in two phase 2 clinical trials for patients with mild to moderate Alzheimer’s, of which we anticipate initiating both by the first quarter of 2024 and exploring the potential for AL001 for patients suffering from [bipolar disorder], [major depressive disorder] and PTSD by submitting investigational new drug applications to the FDA for these indications by the end of 2023.”