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).

Featured Image @ Freepik

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6) This document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect management’s expectations regarding Alzamend Neuro, Inc.’s future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. Wherever possible, words such as “predicts”, “projects”, “targets”, “plans”, “expects”, “does not expect”, “budget”, “scheduled”, “estimates”, “forecasts”, “anticipate” or “does not anticipate”, “believe”, “intend” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative or grammatical variation thereof or other variations thereof, or comparable terminology have been used to identify forward-looking statements. These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to Alzamend Neuro, Inc.’s industry; (b) market opportunity; (c) Alzamend Neuro, Inc.’s business plans and strategies; (d) services that Alzamend Neuro, Inc. intends to offer; (e) Alzamend Neuro, Inc.’s milestone projections and targets; (f) Alzamend Neuro, Inc.’s expectations regarding receipt of approval for regulatory applications; (g) Alzamend Neuro, Inc.’s intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) Alzamend Neuro, Inc.’s expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute Alzamend Neuro, Inc.’s business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) Alzamend Neuro, Inc.’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) Alzamend Neuro, Inc.’s ability to enter into contractual arrangements with additional parties; (e) the accuracy of budgeted costs and expenditures; (f) Alzamend Neuro, Inc.’s ability to attract and retain skilled personnel; (g) political and regulatory stability; (h) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (i) changes in applicable legislation; (j) stability in financial and capital markets; and (k) expectations regarding the level of disruption to as a result of CV-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of Alzamend Neuro, Inc. to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) Alzamend Neuro, Inc.’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises such as CV-19 may adversely impact Alzamend Neuro, Inc.’s business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing Alzamend Neuro, Inc.’s business operations (e) Alzamend Neuro, Inc. may be unable to implement its growth strategy; and (f) increased competition.

Except as required by law, Alzamend Neuro, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Neither does Alzamend Neuro, Inc. nor any of its representatives make any representation or warranty, express or implied, as to the accuracy, sufficiency or completeness of the information in this document. Neither Alzamend Neuro, Inc. nor any of its representatives shall have any liability whatsoever, under contract, tort, trust or otherwise, to you or any person resulting from the use of the information in this document by you or any of your representatives or for omissions from the information in this document.

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