Alzamend Neuro announced that it has successfully identified a maximum tolerated dose, or 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 three-times daily, is designed to be unlikely to require lithium therapeutic drug monitoring. 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 FDA and is still a first-line treatment option 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. AL001 has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. These results identified a safe and appropriate dose to explore the potential for AL001 to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts, thereby avoiding the disadvantages of currently approved lithium salts.
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