Alzamend Seeks to to Test AL001 as Dementia Therapy
Alzamend Neuro has requested approval from the U.S. Food and Drug Administration (FDA) to begin clinical trials to test AL001, its investigational lithium-based ionic cocrystal oral therapy for dementia related to Alzheimer’s disease.
The request was made in the form of an investigational new drug (IND) application that, if approved, will allow the start of Alzamend’s Phase 1 trial of AL001 evaluating AL001’s safety and appropriate dosing for future studies.
“This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline. We believe AL001 could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating Alzheimer’s disease and other neurodegenerative diseases and psychiatric disorders,” Stephan Jackman, CEO of Alzamend, said in a press release. “We look forward to providing more details on the timeline and market opportunity following FDA clearance of the IND, if obtained.”
Using crystal engineering Alzamend has developed AL001, an ionic cocrystal of lithium. Ionic cocrystals are made up of an organic molecule and an inorganic salt, like lithium. This specific formulation of lithium is expected to be safer and therapeutically better than the existing lithium-based treatments.
Recent research has suggested that lithium can be beneficial for the treatment and prevention of Alzheimer’s. According to the company, findings from clinical studies suggested that lithium can preserve cognition and delay dementia, while reducing biomarkers linked with Alzheimer’s disease.
In a mouse model of Alzheimer’s disease, treatment with AL001 prevented cognitive impairment, depression, and irritability. It also improved learning and memory when compared with other lithium formulations.
Following the initial Phase 1 trial, Alzamend plans to assess the safety, tolerability, and preliminary efficacy of AL001 in a Phase 1/2a study in patients with Alzheimer’s. If the data is positive, the company then will initiate a Phase 2b study to identify the right doses for a future Phase 3 safety/efficacy clinical program needed for regulatory approval.
As lithium has been on the market for many years for several medical disorders, and has already demonstrated safety, the regulatory burden and development timeline for AL001 might be shortened.
Alzamend also plans to develop its therapeutic vaccine, AL002, for the treatment of Alzheimer’s. The therapy is designed to stimulate the immune system and prevent harmful beta-amyloid buildup in the brains of people with Alzheimer’s. AL002 is currently in pre-clinical development.