Alzamend Neuro, Inc. announced that it has submitted an investigational new drug application to the U.S. Food and Drug Administration for the initiation of study AL001-PTSD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for treatment of patients with PTSD. Although lithium products do not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. In particular, treatment with low doses (300-600 mg/day) of lithium carbonate have been reported to provide effective treatment in reduction of inappropriate anger, irritability, anxiety, and insomnia in those patients.

The clinical observation of mood swings beyond the normal range, but milder than those associated with BD, reportedly suggested the presence of a sub-threshold mood disorder in these PTSD patients. It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD may be provided by pharmacological induction of a mild transient amnesia. Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option (cons considered the "gold standard") for BD but is underutilized perhaps because of the need for therapeutic drug monitoring ("TDM"), that is, routine monitoring of lithium drug levels in blood to help assure safety and effectiveness.

Lithium was the first drug that required TDM by regulatory authorities in product labelling because the effective and safe range of therapeutic drug blood concentrations is narrow and well-defined for treatment of BD when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness. AL001 is a novel lithium-delivery system that has the potential to provide benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.

Results from Alzamend's recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer's patients and healthy subjects identified a maximum tolerated dose ("MTD") that was vetted by an independent safety review committee. This MTD is designed to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts. This MTD was assessed to be unlikely to require TDM.

After receipt of a " study may proceed" communication from FDA, Alzamend plans to initiate a Phase IIA study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in PTSD patients. Alzamend anticipates that the new drug application ("NDA") development program for PTSD may, for safety, qualify for a 505(b)(2) NDA pathway to FDA approval, which can be available to new formulations of an approved drug.