EXCLUSIVE: Alzamend Neuro To Assess AL001 Alzheimer's Candidate Against Commonly Marketed Lithium Salt In Phase 2 Head-To-Head Study

Alzamend Neuro Inc. ALZN has partnered with Massachusetts General Hospital as its contract research organization to conduct a Phase 2 clinical trial of AL001 for Alzheimer’s.

A healthy subjects cohort will also be studied to permit comparisons of their plasma and brain pharmacokinetics to that of Alzheimer’s patients.

Also Read: EXCLUSIVE: Alzamend Neuro To Raise Up To $25M Via Private Placement Of Preferred Shares.

The objective of this trial is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among Alzheimer’s patients and healthy subjects.

By examining the lithium content in patients’ brains and brain structures during treatments, Alzamend aims to predict the minimum dose necessary to achieve the equivalent effectiveness and safety of AL001 in contrast to established lithium salts.

Alzamend says that this study will assist in meeting the regulatory safety standards through the Section 505(b)(2) pathway for FDA approval, specifically designed for new formulations/ delivery systems of an approved drug.

Alzamend previously completed a Phase 2A multiple ascending dose clinical trial, in which it identified a maximum tolerated dose for the development of AL001, as assessed by an independent safety review committee.

This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3 times daily, is designed to be unlikely to require lithium therapeutic drug monitoring (TDM). This MTD is risk mitigated to treat fragile populations, such as Alzheimer’s patients.

“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 6+ million Americans afflicted with Alzheimer’s,” said Stephan Jackman, CEO of Alzamend.

In May, Alzamend Neuro announced its decision to terminate its “at-the-market” equity offering program.

The move, aimed at minimizing uncertainty and preserving shareholder value, saw Alzamend cease further sales of common stock under its at-the-market equity offering, effectively concluding its obligations related to the program.

Price Action: ALZN stock closed at $3.52 on Friday.

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