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 Post-Traumatic Stress 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 patients with Post-Traumatic Stress Disorder (PTSD). 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 treatment without requiring therapeutic drug monitoring, potentially offering an improved safety profile and enhanced brain biodistribution compared to current lithium-based treatments. This study could significantly impact the treatment of the 9+ million Americans affected by PTSD.

Positive

• Partnership with prestigious Massachusetts General Hospital for Phase II clinical trial
• Potential for AL001 to offer improved safety profile over current lithium treatments
• AL001 designed to not require therapeutic drug monitoring
• Successful completion of Phase IIA multiple ascending dose clinical trial
• Identified maximum tolerated dose for AL001 development

Negative

• AL001 still in early clinical stages, with no guarantee of FDA approval
• Potential competition from existing lithium-based treatments
• Narrow therapeutic window for lithium treatments remains a challenge

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 AL001 to existing lithium carbonate products in PTSD patients could potentially lead to a breakthrough in treatment options. Key points to consider:

• The involvement of Harvard University Associate Professor Dr. Ovidiu Andronesi as the principal investigator adds credibility to the study.
• The trial aims to determine the optimal dose of AL001 that is both safe and effective, potentially eliminating the need for therapeutic drug monitoring.
• If successful, AL001 could address the limitations of current lithium-based treatments, including narrow therapeutic window and chronic toxicity.

While promising, investors should note that Phase II trials still carry significant risks and success is not guaranteed. The potential market impact could be substantial if AL001 proves superior to existing treatments for the 9+ million Americans with PTSD.

Financial Analyst

This news represents a potentially significant milestone for Alzamend Neuro (NASDAQ: ALZN). Key financial implications include:

• Partnering with a prestigious institution like Massachusetts General Hospital could enhance investor confidence and potentially attract more institutional interest.
• The focus on the 505(b)(2) pathway for FDA approval could lead to a faster and less costly development process, potentially conserving cash resources.
• If successful, AL001 could tap into the substantial PTSD market, offering a new revenue stream for Alzamend.

However, it's important to note that the company is still in the clinical stage, with no approved products or revenue. The success of this trial is critical for Alzamend's future prospects. Investors should closely monitor the trial's progress and any updates on the company's cash position and burn rate.

Psychiatry Expert

The potential of AL001 in PTSD treatment is intriguing from a psychiatric perspective. Key considerations:

• Lithium's efficacy in mood disorders is well-established, but its use in PTSD is less common due to side effects and monitoring requirements.
• If AL001 can provide the benefits of lithium with an improved safety profile and no need for therapeutic drug monitoring, it could be a game-changer in PTSD treatment.
• The study's focus on brain lithium levels could provide valuable insights into the mechanism of action and optimal dosing for PTSD patients.

However, it's important to note that this is still early-stage research. While the potential is exciting, we need to see the full results of the Phase II trial before drawing conclusions about AL001's efficacy and safety in PTSD treatment.

• 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 PTSD. 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.

PTSD Symptom Word Soup. All rights reserved @2023 licensed from Adobe Stock

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 PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. In particular, treatment with low doses (300–600 mg/day) of lithium carbonate have been reported to provide effective treatment in reduction of inappropriate anger, irritability, anxiety, and insomnia in those patients. The clinical observation of mood swings beyond the normal range, but milder than those associated with BD, reportedly suggested the presence of a sub-threshold mood disorder in these PTSD patients. It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD may be provided by pharmacological induction of a mild transient amnesia.

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 PTSD 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 9+ million Americans afflicted with PTSD. 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/20240819092808/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 Post-Traumatic Stress Disorder (PTSD).

Who is leading the Phase II clinical trial for Alzamend Neuro's AL001?

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

What potential advantage does AL001 (ALZN) offer over current lithium treatments?

AL001 is designed to provide lithium treatment without requiring therapeutic drug monitoring, potentially offering an improved safety profile and enhanced brain biodistribution compared to current lithium-based treatments.

What was the outcome of Alzamend Neuro's Phase IIA trial for AL001?

Alzamend Neuro successfully completed a Phase IIA multiple ascending dose clinical trial, identifying a maximum tolerated dose for AL001 development.