Alzamend Neuro (ALZN) Partners with Massachusetts General Hospital for Phase 2 PTSD Trial; Shares Soar 358%

Alzamend Neuro (Nasdaq:ALZN), today’s PRISM Mental Health Index leader, saw its shares skyrocket 358% following the announcement of a partnership with Massachusetts General Hospital to conduct a Phase II clinical trial of AL001, its next-generation lithium therapeutic drug candidate targeting patients with post-traumatic stress disorder (PTSD). Although lithium is not FDA-approved for PTSD, low doses have shown promise in reducing symptoms such as anger, irritability, anxiety, and insomnia in patients.

The primary goal of the study is to determine an optimal dose of AL001 that matches the effectiveness and safety of current lithium-based treatments while offering improved safety and biodistribution in the brain. Alzamend aims to use these findings to meet regulatory safety standards and pursue FDA approval through the 505(b)(2) pathway.

“We are elated to partner with Massachusetts General Hospital and Dr. Andronesi in this pivotal study for our lead therapeutic candidate AL001,” said Stephan Jackman, Chief Executive Officer of Alzamend. “If we can develop a next-generation lithium product (AL001) with an improved safety profile and enhanced biodistribution in the brain that would not routinely require TDM, it would constitute a major improvement over current lithium-based treatments and positively impact the 9+ million Americans afflicted with PTSD. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”

Previously, Alzamend completed a Phase IIA trial where it successfully identified the maximum tolerated dose (MTD) for AL001, which is designed to avoid the need for therapeutic drug monitoring (TDM).