Alzamend Neuro Contracts with Altasciences and iResearch Atlanta to Manage and Conduct Its Phase IIA Study in Patients with Alzheimer’s

Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it contracted with Altasciences Clinical Kansas (“Altasciences”) and iResearch Atlanta, LLC (“iResearch”) to manage and conduct, respectively, its Phase IIA multiple ascending dose (“MAD”) study in patients with mild to moderate Alzheimer’s Disease (“Alzheimer’s”). The Phase IIA Study, which is expected to commence enrollment in May 2022, is for the purposes of evaluating the safety and tolerability of AL001 under multiple-dose, steady-state conditions, and to determine the maximum tolerated dose in patients with mild to moderate Alzheimer’s. AL001 is a novel lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic co-crystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s. AL001 has the potential to deliver the clinical benefits of marketed lithium carbonate but with reduced risk of side effects.

“Our Phase I study was successfully conducted with Altasciences and we are excited to continue this partnership,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are also thrilled to add iResearch Atlanta to the team and have full confidence in their ability to execute our Phase IIA MAD study. We believe AL001 could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating Alzheimer’s and other neurodegenerative diseases and psychiatric disorders. We look forward to providing more details following the commencement of the Phase II MAD study for AL001.”

About AL001 Phase I Study

During this Phase 1 trial, participants received a single dose of AL001 containing lithium in an amount equivalent to 150 mg lithium carbonate, a dose proposed as likely appropriate for Alzheimer’s treatment when given three times daily. Currently, marketed lithium carbonate 300 mg capsules are given three times daily when prescribed for manic episodes in bipolar disorder as well as for maintenance therapy of bipolar disorder in patients with a history of manic episodes. It can be difficult to control the appropriate dose of lithium salt formulations, including lithium carbonate, due to the small margin between effective and toxic blood levels, and therefore it can be challenging to avoid side effects or inadequate treatment outcomes.