EXCLUSIVE: Alzamend Neuro Seeks FDA Approval For Mid-Stage PTSD Study With Next‑Gen Lithium Therapeutic Drug Candidate

Alzamend Neuro Inc 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). 

Last month, Benzinga exclusively reported that Alzamend Neuro submitted an IND application to the FDA to initiate AL001-MDD01, a Phase 2A plasma/brain pharmacokinetics study of AL001 for adjunctive treatment of patients with major depressive disorder.

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. 

Also Read: EXCLUSIVE: Alzamend Neuro To Start Next-Gen Therapy Study For Bipolar Disorder.

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. 

Alzamend Neuro approved a one-for-fifteen reverse stock split of its common stock, effective October 31, to regain compliance with Nasdaq's Minimum Bid Price Requirement of $1.00 per share.

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