Alzamend Neuro begins phase II PTSD treatment study

ATLANTA - Alzamend Neuro, Inc. (NASDAQ: ALZN), a clinical-stage biopharmaceutical company, has announced a partnership with Massachusetts General Hospital to conduct a Phase II clinical trial of its drug candidate AL001 for the treatment of post-traumatic stress disorder (PTSD). The study aims to compare the lithium levels in the brain and brain structures of PTSD patients when treated with AL001 versus a commonly used lithium carbonate product.

The trial, which will be led by Dr. Ovidiu Andronesi, Associate Professor of Radiology at Harvard University, seeks to establish the minimum effective and safe dose of AL001, potentially improving the treatment for the 9+ million Americans suffering from PTSD. Alzamend's AL001 is a novel lithium-delivery system designed to offer the benefits of lithium while reducing the toxicity often associated with current lithium-based treatments.

Lithium carbonate has been a first-line treatment for bipolar disorder (BD) for over 35 years and has also shown potential in treating PTSD symptoms such as anger, irritability, anxiety, and insomnia. The upcoming study will further investigate the use of lithium in PTSD treatment, which does not currently have an FDA-approved indication for this use.

Alzamend Neuro previously completed a Phase IIA trial, identifying a maximum tolerated dose for AL001, which is less likely to require therapeutic drug monitoring, a process needed for FDA-approved lithium salts due to their narrow therapeutic window. The new lithium-delivery system aims to improve brain bioavailability and safety profile, potentially eliminating the need for frequent plasma level monitoring.

The company's CEO, Stephan Jackman, expressed enthusiasm about the partnership with Massachusetts General Hospital and the potential benefits of AL001 in treating PTSD. Alzamend Neuro is committed to developing and marketing safe and effective treatments for Alzheimer’s, BD, MDD, and PTSD.

This news is based on a press release statement from Alzamend Neuro, Inc. The company has not yet provided details regarding the study’s timeline or market opportunity.

In other recent news, Alzamend Neuro has initiated a Phase II clinical trial for AL001, a novel lithium-delivery system, in partnership with Massachusetts General Hospital. The trial aims to establish the minimum effective dose of AL001 for treating major depressive disorder (MDD), potentially benefiting over 21 million Americans affected by the condition. Additionally, Alzamend Neuro has announced a one-for-ten reverse stock split and secured an extension for its Nasdaq listing.

In other developments, the company's shareholders approved a significant conversion of preferred stock into common shares and warrants, potentially allowing for a purchase price of up to $25 million. Meanwhile, Ascendiant Capital has adjusted its outlook on Alzamend Neuro, reducing the 12-month price target to $21 from the previous $25, while maintaining a Buy rating on the stock.

These recent developments underscore Alzamend Neuro's ongoing efforts in the biopharmaceutical sector, focusing on developing treatments for neurological disorders.

InvestingPro Insights

As Alzamend Neuro, Inc. (NASDAQ: ALZN) embarks on a promising Phase II clinical trial for its drug candidate AL001, potential investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro data, Alzamend's market capitalization stands at a modest $1.72 million, reflecting the size and speculative nature of the biopharmaceutical firm at this stage of its development.

InvestingPro Tips highlight some financial challenges and market trends that are essential for investors to consider. Alzamend is quickly burning through cash, which is a critical factor for a clinical-stage company that has yet to commercialize a product. Additionally, the company suffers from weak gross profit margins and is not expected to be profitable this year, which is not uncommon in the biotech industry where upfront costs are high and profits are typically realized after successful product development and market approval.

On the market side, Alzamend's stock has experienced a significant decline, with a one-year price total return of -95.17%. This performance may raise concerns about investor confidence and the company's ability to raise additional funds if needed. However, it's worth noting that the biotech sector can be highly volatile, and early-stage companies like Alzamend can see large swings in their stock price based on clinical trial outcomes and regulatory news.

For those interested in a deeper dive into Alzamend Neuro's financials and market performance, InvestingPro offers additional insights, with 14 more InvestingPro Tips available for review at https://www.investing.com/pro/ALZN. These tips can provide a more comprehensive understanding of the company's position and prospects, helping investors make informed decisions.

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