Alzamend Neuro gets ‘Study May Proceed’ letter for AL001 from FDA to treat MLS

Alzamend Neuro announced receipt of a “Study May Proceed” letter from the U.S. Food and Drug Administration FDA for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for treatment of patients with MDD. “We are grateful to receive this timely, favorable response from the FDA to initiate our first Phase IIA clinical study of AL001 for 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. “If we can develop a next-generation lithium product or 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 21M Americans afflicted with MDD. We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”