EXCLUSIVE: Alzamend Neuro Plans To Kickstart Stress Disorder Study With Next-Gen Lithium Product Next Year

Alzamend Neuro Inc ALZN received a "Study May Proceed" letter from the FDA for the initiation of study AL001-PTSD01, a Phase 2A study of AL001 for post-traumatic stress disorder (PTSD). 

"Although lithium does not have an FDA-approved indication for PTSD, it has been prescribed off-label for this purpose for decades," said Stephan Jackman, Chief Executive Officer of Alzamend. 

"If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring (TDM), it would constitute a major improvement over current lithium-based treatments and positively impact the 9 million Americans afflicted with PTSD."

The company they are advancing the process and expects that the first patient will be dosed in the first quarter of 2024.

Alzamend's recently completed Phase 2A study of AL001 in Alzheimer's patients and healthy subjects showed a benign safety profile and identified a candidate dose unlikely to require therapeutic drug monitoring.

Last month, Benzinga exclusively reported that Alzamend Neuro received a "Study May Proceed" letter from the FDA to initiate study AL001-MDD01 Phase 2A study of AL001 for major depressive disorder. 

Price Action: ALZN shares closed at $1.07 on Friday.