EXCLUSIVE: Alzamend Seeks FDA Approval For Study For Upgraded Version Of Most Commonly Used Treatment For Bipolar Disorder

Alzamend Neuro Inc (NASDAQ: ALZN) has submitted an investigational new drug (IND) application to the FDA to initiate AL001-BD01, a Phase 2A study of AL001 for bipolar disorder. 

Lithium is a commonly prescribed drug for manic episodes in bipolar disorder type 1 and maintenance therapy for bipolar disorder in patients with a history of manic episodes.

AL001 is a novel lithium-delivery system that can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. 

Alzamend tells Benzinga that lithium carbonate is currently off-patent, but AL001 would be on-patent until 2034 for the Composition of Matter and 2036 for the Method of Delivery.

The company tells Benzinga this is a head-to-head" AL001 vs. Lithium Carbonate "Lithium in the brain" study. The Phase 1 study demonstrated greater biodistribution of lithium in plasma, and the company's published mouse studies predicted lithium can be given at lower doses for equivalent therapeutic benefit when treated with AL001. 

The company aims to quantify a greater biodistribution in human brains.

Results from Alzamend's recently completed Phase 2A multiple-ascending dose study of AL001 in Alzheimer's and healthy patients suggested a maximum tolerated dose at 240mg 3 times daily (TID).

Once the FDA clears the IND, Alzamend intends to initiate the Phase 2A study to determine relatively increased lithium levels in the brain compared to a marketed lithium salt in bipolar disorder patients.

Alzamend aims to replace a 300 mg TID lithium carbonate dose for bipolar disorder with a 240 mg TID AL001 lithium equivalent, representing a daily decrease of 20% of lithium given to a patient.

Price Action: ALZN shares closed at $0.28 on Tuesday.