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Mental health issues are on the rise, affecting almost 60 million US adults and more than 970 million people worldwide.¹ Rising cases has led to an uptick in new treatments moving through the clinical stages, including Alzamend Neuro, Inc. (NASDAQ:ALZN), which is focused on developing next-generation treatments for Alzheimer’s disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). Among its promising pipeline, AL001 stands out as a potential game-changer for bipolar disorder treatment.

Alzamend Neuro's AL001, a patented ionic cocrystal technology, aims to deliver lithium in a way that reduces toxicity while maintaining therapeutic efficacy by combining lithium, salicylate, and L-proline.

Alzamend Neuro is rapidly advancing treatments for mental health disorders, potentially accelerating clinical phase progress due to the successes of AL001 in a Phase I and Phase IIA clinical trials for the treatment of Alzheimer’s. In 2023, the company filed IND applications for Phase IIA Clinical Trials of AL001 for Bipolar Disorder, MDD and PTSD. By the end of 2023, the FDA granted approval for these studies via “Study may proceed” letters.

Alzamend Neuro Partners with MGH for Phase II Trial of Next-Generation Lithium Therapeutic Drug Candidate for Bipolar Disorder

On August 6th, Alzamend Neuro, Inc. (NASDAQ:ALZN) announced a partnership with Massachusetts General Hospital (MGH) to conduct a Phase II clinical trial of AL001 for treatment of patients with bipolar disorder. MGH, the primary clinical education and research facility of Harvard Medical School, is the world's largest hospital-based research program.

Dr. Ovidiu Andronesi MD, PhD, Associate Professor of Radiology at Harvard University and Director of Multinuclear Metabolic Imaging at the Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, will lead the study as the Principal Investigator. The trial will compare AL001 to a marketed lithium carbonate product, focusing on bioavailability and brain distribution of lithium, with the goal of establishing AL001's safe, effective, and tolerable dosing requirements.

AL001 is designed to offer the therapeutic benefits of traditional lithium salts while minimizing their toxic side effects. This head-to-head study will measure lithium levels in the brain and structures of bipolar disorder patients, building on mouse studies that suggest AL001 can achieve therapeutic benefits at lower doses. The study will also leverage brain imaging to predict the efficacy and safety of AL001 compared to existing lithium treatments.

Alzamend Neuro's previous Phase IIA studies of AL001 in Alzheimer's patients and healthy subjects have demonstrated a benign safety profile, identifying a candidate dose unlikely to require therapeutic drug monitoring (TDM). This is a significant advancement, as current lithium treatments require rigorous monitoring due to their narrow therapeutic window and potential toxicity.

“We are elated to partner with Massachusetts General Hospital and Dr. Andronesi in this pivotal study for our lead therapeutic candidate AL001,” said Alzamend Neuro, Inc. (NASDAQ:ALZN) CEO Stephan Jackman, “If we can develop a next-generation lithium product (AL001) with an improved safety profile and enhanced biodistribution in the brain that would not routinely require therapeutic drug monitoring (TDM), it would constitute a major improvement over current lithium-based treatments and positively impact the 7+ million Americans afflicted with bipolar disorder. We look forward to providing more details regarding study timelines and market opportunity in the near future.”

This innovation has the potential to positively impact the over 7 million Americans living with bipolar disorder. Further details about the study timelines and market potential will be shared soon.

Alzamend Neuro to Conduct a Phase II Clinical Trial of AL001, involving Patients with Alzheimer’s Disease

Alzamend Neuro, Inc. (NASDAQ:ALZN) also just announced a collaboration with Massachusetts General Hospital (MGH) to conduct A Phase II clinical trial for AL001, for the potential treatment of Alzheimer's disease.

This trial will involve both Alzheimer’s patients and healthy subjects to compare the bioavailability and brain distribution of AL001 versus a marketed lithium carbonate product. The trial, which will also be led by Dr. Ovidiu Andronesi of Harvard University, aim to establish AL001's safe, effective, and tolerable dosing requirements.

The potential to avoid the need for therapeutic drug monitoring (TDM) is also significant, as it could simplify treatment regimens and improve patient compliance. By potentially offering a safer and more effective alternative to traditional lithium treatments, AL001 could revolutionize how Alzheimer's disease is managed.

The ability to measure lithium levels directly in the brain and brain structures using advanced imaging techniques will provide invaluable insights into the drug’s efficacy and safety. This approach not only enhances our understanding of how AL001 works but also supports its potential approval through a Section 505(b)(2) pathway with the FDA. If successful, the trial could pave the way for a new era in Alzheimer's treatment, providing hope for millions of patients and their families.

Financial Support for Clinical Trial

In addition to this groundbreaking partnership, Alzamend Neuro, Inc. (NASDAQ:ALZN) recently secured the first two tranches of a $25 million Series A purchasing agreement.

This investment supports the advancement of Alzamend's clinical trial and the development of next-generation treatments for Alzheimer’s, bipolar disorder, MDD, and PTSD. CEO Stephan Jackman emphasized the company's dedication to advancing clinical milestones and revolutionizing lithium-based therapies for millions affected by these conditions.

Click here for more information about Alzamend Neuro, Inc. (NASDAQ:ALZN).

[1] https://www.who.int/health-topics/mental-health#tab=tab_2

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