EXCLUSIVE: Alzamend Neuro Receives FDA Go-Ahead Letter For Mid-Stage Major Depressive Disorder Study

Alzamend Neuro Inc ALZN has received a "Study May Proceed" letter from the FDA for the initiation of study AL001-MDD01, a Phase 2A clinical study of AL001 for major depressive disorder (MDD). 

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

Also Read: EXCLUSIVE: Alzamend Seeks FDA Approval For Study For Upgraded Version Of Most Commonly Used Treatment For Bipolar Disorder.

"If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the 21 million Americans afflicted with MDD," Jackman added. 

The company said safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval.

Alzamend's recently completed Phase IIA 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.

The company expects to dose the first patient in the first quarter of 2024.

Last week, Benzinga exclusively reported Alzamend Neuro 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). 

Price Action: ALZN shares closed at $1.69 on Friday.

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