Alzamend Neuro teams with MGH for lithium drug AL001 trial to treat PTSD

Alzamend Neuro announced that it is partnering with Massachusetts General Hospital as its contract research organization or CRO to conduct first of its kind Phase II clinical study of AL001 for treatment of patients with PTSD. Massachusetts General Hospital is the original and largest clinical education and research facility of Harvard Medical School/Harvard University and houses the world’s largest hospital-based research program…Alzamend previously completed a Phase IIA multiple ascending dose clinical trial, in which it successfully identified a maximum tolerated dose MTD for development of AL001, as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, is designed to be unlikely to require lithium therapeutic drug monitoring TDM . Current FDA-approved lithium salts are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations. Existing lithium drugs suffer from chronic toxicity, poor physicochemical properties, and poor brain bioavailability. However, because lithium is so effective, it is still used clinically despite its narrow therapeutic index. “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.”