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Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Post-Traumatic Stress Disorder Patients of Next‑Generation Lithium Therapeutic Drug Candidate AL001
Alzamend’s recently completed Phase IIA Study of AL001 in Alzheimer’s patients and healthy subjects showed a benign safety profile and identified a candidate
About this update from Alzamend Neuro, Inc.
[{"type":"text","content":"\n\nAlzamend’s recently completed Phase IIA Study of AL001 in Alzheimer’s patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require therapeutic drug monitoring\n\n\n\nSafety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval\n\n\n\n ATLANTA--(BUSINESS WIRE)--\nAlzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced that it has submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for the initiation of study AL001-PTSD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for treatment of patients with PTSD.\n\n\nAlthough 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.\n\n\nLithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option (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.\n\n\nAL001 is a novel ...