EXCLUSIVE: Alzamend Neuro Submits IND For Phase IIA Trial Of Next-Gen Lithium Candidate In Major Depressive Disorder

Alzamend Neuro Inc ALZN has submitted an investigational new drug (IND) application to the FDA to initiate AL001-MDD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for adjunctive treatment of patients with major depressive disorder (MDD).

Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for treating Alzheimer’s, BD, MDD, and PTSD.

Lithium, although not FDA-approved for MDD augmentation, has been used off-label for years, the company said. 

It’s the FDA’s first-approved mood stabilizer and remains a first-line treatment for BD, but it is underutilized, which may be due to required therapeutic drug monitoring (TDM).

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.

Also Read: EXCLUSIVE: Alzamend Neuro Identifies Potential AL001 Dose Level For Upcoming Alzheimer’s Study

Following the FDA’s ‘study may proceed’ communication, Alzamend aims to start a Phase IIA study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in MDD patients.

Alzamend says this IND submission represents a significant milestone in advancing the company’s proprietary pipeline.

“Being able to develop a next-generation lithium product (AL001) that would not routinely require TDM could positively impact the 21 million Americans afflicted with MDD. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future,” commented Stephan Jackman, Chief Executive Officer of Alzamend.

Price Action: ALZN shares are down 0.55% at $0.20 premarket on the last check Monday.