Alzamend N Neuro, Inc. announced that it has successfully identified a maximum tolerated dose ("MTD") for development of AL001 from a multiple-ascending dose study as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3- times daily ("TID"), is designed to be unlikely to require lithium therapeutic drug monitoring ("TDM"). Also, this MTD is risk mitigated for the purpose of treating fragile populations, such as Alzheimer's patients.

Lithium is a commonly prescribed drug for manic episodes in BPD type 1 as well as maintenance therapy of BPD in patients with a history of a manic episode. Lithium is also prescribed off-label for MDD, BPD and treatment of PTSD, among other disorders. Lithium was the first mood stabilizer approved by the United States Food and Drug Administration ("FDA") and is still a first-line treatment option (cons considered the "gold standard") but is underutilized perhaps because of the need for TDM.

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 BPD when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness. AL001 is a novel lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with neurodegenerative, neurological and neuropsychiatric conditions.

The Phase IIA study evaluated the safety and tolerability of AL001 under multiple-dose, steady--state conditions. In each cohort, consisting of 6 active and 2 placebo subjects (as per randomization), multiple ascending doses were administered TID for 14 days, up to tolerability/safety limits. The safety profile was demonstrated to be benign at all dose levels, and so the selected dose level chosen for further development was based on avoidance of plasma drug concentrations associated in the medical literature with possible toxicity.