Alzamend Neuro Inc (NASDAQ:ALZN) has submitted an investigational new drug (IND) application to the FDA for the initiation of study AL001-PTSD01, a Phase 2A plasma/brain pharmacokinetics study of AL001 for patients with post-traumatic stress disorder (PTSD). 

Results from Alzamend's recently completed Phase 2A multiple-ascending dose study of AL001 in Alzheimer's patients and healthy subjects identified a maximum tolerated dose (MTD) that an independent safety review committee vetted. 

This MTD is designed to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts. 

This MTD was assessed to be unlikely to require therapeutic drug monitoring (TDM). 

After receipt of a "study may proceed" communication from the FDA, Alzamend plans to initiate a Phase 2A study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in PTSD patients. 

Price Action: ALZN shares closed at $1.46 on Friday.