EXCLUSIVE: Alzamend Neuro Identifies Potential AL001 Dose Level For Upcoming Alzheimer's Study

Alzamend Neuro Inc ALZN has identified a maximum tolerated dose (MTD) for developing AL001 from a multiple-ascending dose study as assessed by an independent safety review committee. 

What Happened: The dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3 times daily (TID), is designed to be unlikely to require lithium therapeutic drug monitoring (TDM). 

The Phase 2A study evaluated the safety and tolerability of AL001 under multiple-dose, steady‑state conditions. In each cohort, multiple ascending doses were administered TID for 14 days, up to tolerability/safety limits. 

The safety profile was demonstrated to be benign at all dose levels. So the MTD was based on avoiding plasma drug concentrations associated in the medical literature with possible toxicity. 

Why It Matters: "The company expects to initiate two AL001 Phase 2 trials for patients with mild to moderate Alzheimer's in Q1 of 2024.

It is also exploring the potential for AL001 for patients suffering from BPD, MDD, and PTSD and expects to submit FDA investigational new drug applications by the end of 2023.

The two future clinical trials at the MTD aim to determine the relative increased lithium levels in the brain compared to a marketed lithium salt for Alzheimer's, BPD, MDD, and PTSD, based on published mouse studies that predict that lithium can be given at lower doses for equivalent therapeutic benefit when treating with AL001. 

In April, Alzamend initiated a Phase 1/2A trial for its immunotherapy vaccine (ALZN002) to treat mild to moderate dementia of Alzheimer's type.

Price Action: ALZN shares closed at $0.69 on Wednesday.