On Tuesday, Alzamend Neuro Inc ALZN said it finished analyzing the final full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer’s transgenic mice.
The study involved administering AL001 to 5XFAD mice, a recognized model for Alzheimer’s research, to compare its effects against lithium carbonate, an FDA-approved and marketed API.
Mice received high or low doses scaled to humans of AL001 and lithium carbonate over 14 days to observe pharmacokinetic steady-state drug conditions.
Key Findings:
- Both treatments did not negatively impact the mice’s body weight or clinical signs during the treatment period.
- AL001 showed lower plasma lithium levels than lithium carbonate, reducing the risk of adverse systemic effects and suggesting an expansion for the safety of lithium’s therapeutic index.
- AL001 showed higher lithium concentrations in brain tissues than lithium carbonate, particularly at lower doses.
- The study found that different brain regions absorb and retain lithium differently. This means treatments can potentially be tailored to target specific brain areas.
The company says that the results highlight the potential clinical advantages of AL001 for conditions like Alzheimer’s, bipolar disorder, major depressive disorder, and post-traumatic stress disorder at low doses.
By reducing the systemic burden, AL001 could lessen the risk of side effects such as thyroid and kidney complications often associated with extant lithium therapies, positioning AL001 as a candidate for safer long-term treatment options without the need for routine blood lithium monitoring.
In October, Alzamend Neuro 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.
Price Action: ALZN stock is up 6.67% at $1.44 during the premarket session at last check Tuesday.
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