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EXCLUSIVE: Alzamend Neuro Submits IND For Phase IIA Trial Of Next-Gen Lithium Candidate In Major Depressive Disorder [Yahoo! Finance]

Alzamend Neuro, Inc. (ALZN) 
Company Research Source: Yahoo! Finance
Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for treating Alzheimer's, BD, MDD, and PTSD. Lithium, although not FDA-approved for MDD augmentation, has been used off-label for years, the company said. It's the FDA's first-approved mood stabilizer and remains a first-line treatment for BD, but it is underutilized, which may be due to required therapeutic drug monitoring (TDM). AL001 is a novel lithium-delivery system that can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Following the FDA's ‘study may proceed' communication, Alzamend aims to start a Phase IIA study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in MDD patients. Alzamend says this IND submission represents a significant milestone in advancing the company's proprietary pipeline. “Being able to develop a n Show less Read more
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