Alzamend Neuro Gets FDA Approval for Trial of Depression Treatment

By Dean Seal

Alzamend Neuro has gotten the go-ahead from federal regulators to launch a clinical study of its treatment for major depressive disorder.

The biopharmaceutical company said Monday that it received a "Study May Proceed" letter from the U.S. Food and Drug Administration for a Phase IIA clinical study of AL001.

"We are grateful to receive this timely, favorable response from the FDA," Chief Executive Stephan Jackman said. "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."

Alzamend Neuro expects that the first patient will be dosed in the first quarter of 2024.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

11-20-23 0832ET