Alzamend Neuro Receives Positive FDA Response For Its Depression Candidate

Alzamend Neuro Inc ALZN has received a written response to its meeting request relating to its Type B Pre-Investigational New Drug (IND) application from the FDA.
The FDA’s response provides a path for Alzamend’s planned clinical development of AL001 for bipolar disorder, major depressive disorder (MDD), and post-traumatic stress disorder (PTSD).
In Phase 1, a relative bioavailability comparison of AL001 to lithium carbonate completed in March, AL001 was shown to provide dose-normalized bioequivalent plasma pharmacokinetics, and the observed safety profile was benign.
A Phase 2A trial for dementia related to Alzheimer’s is currently underway. Topline data is expected in December. Alzamend plans to conduct further studies to ascertain comparative brain penetration and persistence of AL001 to lithium carbonate.
Based on the FDA’s written feedback, Alzamend anticipates filing the INDs for bipolar disorder, MDD, and PTSD upon completing the current Phase 2a study. This will allow Alzamend to initiate Phase 2 clinical trials for all three new indications.
Price Action: ALZN shares are up 2.83% at $0.96 during the premarket session on the last check Monday.