Alzamend Neuro Inc (NASDAQ: ALZN) is a clinical-stage biopharma corporation that concentrates on developing novel medicare products that can be used to treat mental disorders and neurodegenerative diseases. The company recently announced that it had received FDA approval to proceed with its Phase I clinical trial of its ionic cocrystal lithium-based oral therapy, AL001. Its a treatment for people with dementia associated with the severe, moderate, and mild cognitive impairments linked to Alzheimer’s.
Alzamend’s Chief Executive Officer, Stephen Jackman, said they were delighted to receive the FDA’s timely and favorable response allowing them to initiate AL001’s Phase I trial. He confirmed that the company was advancing the process, and they expect the administration of the first dose by September this year.
The AL001 Treatment
This patented cocrystal ionic tech offers a therapeutic blend of salicylate, proline, and lithium, called LiProSal, via a pair of exclusive royalty-bearing global licenses from the Research Foundation of the University of Florida.
Based on all the pre-clinical information gathered, AL001 helps prevent irritability, depression, and cognitive deficits in PS1dE9/APPSWE mice. It has also shown that it can help improve irritability and associative memory, and learning. Compared to what lithium carbonate-based treatments can do, the results were quite impressive. Lithium-based therapies have been around for over thirty years. Human toxicology linked to lithium-based therapies is something that’s been both well documented and well characterized. This current information is what the company can potentially rely on, reducing the burden for regulatory safety information.
Alzamend’s product candidates are designed to bring affordable cures or treatments to the market as fast as possible. The company currently has two drug candidates in its pipeline, namely the AL001 treatment and the AL002. Both treatments seek to treat mental disorders.