EXCLUSIVE: Alzamend Neuro Reveals Full Data Set From Multiple Ascending Dose Trial For Lead Candidate For Dementia Related to Alzheimer's

On Wednesday, Alzamend Neuro, Inc. ALZN said it received the final full data set from its multiple ascending dose clinical trial for AL001 for dementia related to Alzheimer's. Preliminary results were released in June 2023.

Identified by an independent safety review committee, this MTD represents a pivotal step forward; it delivers lithium at a lithium carbonate equivalent dose of 240 mg, taken three times daily (TID).

The Phase 2A study evaluated the safety and tolerability of AL001 under multiple-dose, steady‑state conditions.

It determined the MTD in patients diagnosed with mild to moderate Alzheimer's disease and in healthy non-elderly and elderly subjects with adequate renal function.

Lithium has been well characterized for safety and is approved and marketed in multiple formulations for bipolar disorder.

• The safety profile was demonstrated to be benign at all dose levels. The dose level chosen for further development was based on avoiding plasma drug concentrations associated in the medical literature with exceeding the upper limit of the therapeutic range of drug concentrations, thereby mitigating potential toxicity.
• Under the conditions of this study, multiple-dose administrations of AL001 were well tolerated in healthy elderly and non-elderly subjects, as well as in subjects with Alzheimer's, regardless of their comorbidities.
• No clinically obvious or relevant lithium or salicylate pharmacokinetic differences were observed between non-elderly and elderly healthy subjects, or Alzheimer's subjects under the conditions of this study.

Based on the results from this study, Alzamend plans to initiate five clinical trials to determine the relative increased lithium levels in the brain compared to a marketed lithium salt for healthy subjects and patients diagnosed with mild to moderate Alzheimer's, bipolar disorder, major depressive disorder and post-traumatic stress disorder, based on published mouse studies that predict that lithium can be given at lower doses for equivalent therapeutic benefit when treating with AL001.

In August, Alzamend Neuro exclusively told Benzinga that it partnered with Massachusetts General Hospital as its contract research organization to conduct a Phase 2 trial 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.

Price Action: ALZN stock closed at $1.67 on Tuesday.

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