Alzamend Neuro Partners with Massachusetts General Hospital for a Phase II Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, involving Patients with Major Depressive Disorder

Rhea-AI Summary

Alzamend Neuro (Nasdaq: ALZN) has partnered with Massachusetts General Hospital for a Phase II clinical trial of AL001, a next-generation lithium therapeutic drug candidate for Major Depressive Disorder (MDD). The study, led by Harvard University Associate Professor Dr. Ovidiu Andronesi, aims to compare AL001 with a marketed lithium carbonate product to identify an ideal dose that is safe and effective.

AL001 is designed to provide lithium at a carbonate equivalent dose of 240 mg 3-times daily, potentially eliminating the need for therapeutic drug monitoring. This could be a significant improvement over current lithium-based treatments, which require regular monitoring due to a narrow therapeutic window. The study's objective is to assess the comparative increase in lithium levels within the brain and its structures, potentially impacting the 21+ million Americans afflicted with MDD.

Positive

• Partnership with prestigious Massachusetts General Hospital for Phase II clinical trial
• Potential for AL001 to eliminate need for therapeutic drug monitoring
• AL001 may offer improved safety profile and enhanced brain biodistribution
• Successful identification of maximum tolerated dose in previous Phase IIA trial
• Potential to impact treatment for over 21 million Americans with MDD

Negative

• AL001 still in early clinical stages, with no guarantee of success
• Potential regulatory hurdles in gaining FDA approval
• Competition from existing lithium-based treatments and other antidepressants

Insights

Medical Research Analyst

This partnership with Massachusetts General Hospital for a Phase II clinical trial of AL001 is a significant development for Alzamend Neuro. The study's focus on comparing brain lithium levels between AL001 and existing lithium carbonate products could potentially revolutionize MDD treatment.

Key points to consider:

• AL001 aims to improve upon current lithium treatments by potentially eliminating the need for therapeutic drug monitoring.
• The involvement of Dr. Andronesi, a Harvard professor and expert in biomedical imaging, lends credibility to the study.
• If successful, AL001 could address the limitations of existing lithium drugs, including chronic toxicity and poor brain bioavailability.

While promising, investors should note that Phase II trials still carry significant risks and success is not guaranteed. The potential market impact, however, is substantial given the 21+ million Americans affected by MDD.

Financial Analyst

This clinical trial partnership represents a strategic move for Alzamend Neuro (NASDAQ: ALZN). Key financial implications include:

• Potential to tap into the lucrative MDD market, which could significantly boost revenue if AL001 proves successful.
• Collaboration with a prestigious institution like Massachusetts General Hospital may enhance investor confidence and potentially attract more funding.
• The 505(b)(2) pathway could lead to faster and less costly FDA approval, potentially accelerating time-to-market.

However, investors should be cautious. Clinical trials are expensive and positive results are not guaranteed. The company's financial health and burn rate should be closely monitored. If successful, AL001 could be a game-changer for Alzamend, but it's important to balance optimism with the inherent risks of drug development.

Psychiatric Expert

The potential of AL001 in MDD treatment is clinically significant. Current lithium treatments, while effective, are hampered by a narrow therapeutic window and the need for frequent monitoring. AL001's promise lies in its potential to:

• Provide a safer lithium-based treatment with reduced toxicity risks.
• Improve patient compliance by eliminating the need for regular therapeutic drug monitoring.
• Enhance efficacy through better brain bioavailability.

The head-to-head comparison with existing lithium carbonate products is crucial. If AL001 demonstrates superior brain penetration at lower doses, it could become a preferred option for both monotherapy and augmentation in MDD. However, it's important to note that while lithium has shown efficacy in MDD, it's not yet FDA-approved for this indication. The study's results could potentially pave the way for broader applications of lithium in psychiatry.

• Harvard University Associate Professor, Dr. Ovidiu Andronesi MD, PhD, will be the principal investigator of the study
• Head-to-head study of AL001 versus a marketed lithium carbonate product will be conducted; the goal is to compare lithium in human brain and brain structures to identify a potentially ideal dose of AL001 that is safe and effective as current products

ATLANTA--(BUSINESS WIRE)-- Alzamend 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 is partnering with Massachusetts General Hospital as its contract research organization (“CRO”) to conduct first of its kind Phase II clinical study of AL001 for treatment of patients with MDD. Massachusetts General Hospital is the original and largest clinical education and research facility of Harvard Medical School/Harvard University and houses the world's largest hospital-based research program.

Massachusetts General Hospital (Photo: Business Wire)

Alzamend and Mass General have contracted with Dr. Ovidiu Andronesi MD, PhD, to be the principal investigator on the study. Dr. Andronesi is an Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital.

Lithium was the first mood stabilizer approved by the U.S. Food and Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”) for BD. Moreover, lithium has been marketed for more than 35 years and human toxicology regarding its use has been well characterized, potentially mitigating the regulatory burden for safety data. Although lithium does not have an FDA approved indication for augmentation of an antidepressant in MDD, it has been prescribed off-label for this purpose for decades. While a wide variety of medications have been used historically in this capacity, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials. Although the ideal role for lithium augmentation has yet to be established, there is evidence to support the clinical practice of adding lithium to conventional antidepressants in pursuit of MDD remission.

The objective of this novel trial is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among MDD patients. By examining the lithium content in the brains and brain structures of patients during treatments, Alzamend aims to predict the minimum dose necessary to achieve the equivalent effectiveness and safety of AL001 in contrast to established lithium salts. Alzamend is optimistic that this study will assist in meeting the regulatory safety standards through the Section 505(b)(2) pathway for approval by the U.S. Food and Drug Administration, which is specifically designed for new formulations/ delivery systems of an approved drug.

Alzamend previously completed a Phase IIA multiple ascending dose clinical trial, in which it successfully identified a maximum tolerated dose (“MTD”) for development of AL001, as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”). Current FDA-approved lithium salts (carbonate and citrate) are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations. Existing lithium drugs suffer from chronic toxicity, poor physicochemical properties, and poor brain bioavailability. However, because lithium is so effective, it is still used clinically despite its narrow therapeutic index.

“We are elated to partner with Massachusetts General Hospital and Dr. Andronesi in this pivotal study for our lead therapeutic candidate AL001,” said Stephan Jackman, Chief Executive Officer of Alzamend. “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 TDM, it would constitute a major improvement over current lithium-based treatments and 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.”

About AL001

AL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified an MTD, as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in the brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts. This can serve to mitigate or obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers.

About Alzamend Neuro

Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s by removing beta-amyloid from the brain. The latter is a second-generation active-immunity approach designed to mitigate the disadvantages of approved passive immunity marketed antibody products, particularly by reducing the required frequency and costs of dosing associated with antibody products. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240812438959/en/

Email: Info@Alzamend.com or call: 1-844-722-6333

Source: Alzamend Neuro, Inc.

FAQ

What is the purpose of Alzamend Neuro's Phase II clinical trial for AL001?

The Phase II clinical trial aims to compare AL001 with a marketed lithium carbonate product to identify an ideal dose that is safe and effective for treating Major Depressive Disorder (MDD), potentially eliminating the need for therapeutic drug monitoring.

Who is leading the AL001 Phase II clinical trial for Alzamend Neuro (ALZN)?

The principal investigator for the study is Dr. Ovidiu Andronesi, an Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging at Massachusetts General Hospital.

What advantages could AL001 offer over current lithium-based treatments for MDD?

AL001 is designed to provide lithium at a carbonate equivalent dose of 240 mg 3-times daily, potentially eliminating the need for therapeutic drug monitoring and offering an improved safety profile with enhanced brain biodistribution compared to current lithium-based treatments.

How many Americans could potentially benefit from Alzamend Neuro's (ALZN) AL001 treatment?

According to the press release, AL001 could potentially impact the treatment of over 21 million Americans afflicted with Major Depressive Disorder (MDD).