FDA provides guidance to Alzamend ahead of IND application for oral therapeutic

The FDA has provided guidance to biopharmaceutical company Alzamend Neuro Inc. regarding its development of an oral therapeutic to treat a range of psychological disorders.

In a company release, Alzamend stated the FDA issued a written response to its meeting request relating to its Type B Pre-Investigational New Drug application for AL001, a lithium-salicylate-L-proline engineered ionic cocrystal currently under development as an oral treatment for patients with dementia resulting from mild, moderate or severe cognitive impairment caused by Alzheimer’s. The FDA’s response clears the way for Alzamend’s planned clinical development of AL001 for the treatment of bipolar disorder, major depressive disorder and PTSD.

“We appreciate the thorough and meaningful response from the FDA, which provides us with the information and clarity needed to submit IND applications to initiate clinical trials for AL001,” Alzamend CEO Stephan Jackman said in the release.

An ongoing phase 2a study is evaluating the safety and tolerability of AL001 under multiple-dose, steady-state conditions, per the release. The study, which began in May and could include up to 40 participants, aims to determine the maximum tolerated dose in patients diagnosed with mild to moderate Alzheimer’s.

Based on the FDA’s feedback, Alzamend anticipates filing the INDs for bipolar disorder, MDD and PTSD upon the completion of the current phase 2a multiple ascending dose study. This will allow Alzamend to initiate phase 2 trials for all three new indications.

“We are one step closer to substantiating that AL001 can potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million Americans suffering from Alzheimer’s, bipolar disorder, MDD, and PTSD,” Jackman said.

Editor’s note: This story was updated July 27, 2022, to remove some inaccurate information. Healio regrets the error.