Alzamend Neuro to Present Non-Clinical Data Update at the Society of Toxicology 2025 Annual Meeting and ToxExpo

Rhea-AI Summary

Alzamend Neuro (NASDAQ: ALZN) announced its upcoming poster presentation at the Society of Toxicology Annual Meeting in March 2025, featuring non-clinical data on AL001, a lithium-based treatment. The presentation will showcase comparative data between AL001 and lithium carbonate in Alzheimer's transgenic mice. Key findings demonstrate AL001's enhanced brain-specific lithium delivery with minimized systemic exposure, showing no adverse effects while maintaining higher brain lithium concentrations at lower doses compared to lithium carbonate.

Following successful Phase I and IIA trials, Alzamend plans five Phase II trials in partnership with Massachusetts General Hospital in 2025, targeting treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. The company aims to pursue FDA 505(b)(2) approval pathway for AL001.

Positive

• AL001 demonstrated superior brain penetration with higher lithium concentrations at lower doses
• No adverse effects observed in preclinical studies
• Lower systemic exposure compared to traditional lithium carbonate
• Advancement to five Phase II trials following successful Phase I and IIA results
• Potential qualification for expedited FDA 505(b)(2) approval pathway

Negative

• Results to preclinical mouse studies, human efficacy yet to be proven

Insights

Medical Research Analyst

The non-clinical data presentation for AL001 reveals promising pharmacokinetic properties that could represent a significant advancement in lithium-based therapies. The key finding of enhanced brain penetration with lower systemic exposure addresses one of the main limitations of traditional lithium treatments - the narrow therapeutic window that often leads to toxicity concerns.

The data showing higher brain lithium concentrations at lower doses compared to lithium carbonate is particularly significant from a development perspective. This could translate to improved safety profiles while maintaining or potentially enhancing therapeutic efficacy. The region-specific absorption patterns in the brain also suggest possibilities for more targeted treatment approaches.

However, while these preclinical results are encouraging, investors should note that the upcoming five Phase II trials in 2025 will be important in validating these benefits in human subjects. The 505(b)(2) pathway could accelerate development, but success in these trials remains the critical next milestone.

Pharmaceutical Industry Analyst

The development strategy for AL001 appears well-structured, with the company leveraging the 505(b)(2) regulatory pathway which could potentially reduce development time and costs. The partnership with Massachusetts General Hospital for multiple Phase II trials adds credibility to the program and suggests confidence in the preliminary data.

The market opportunity is substantial, spanning multiple major indications including Alzheimer's disease, bipolar disorder, major depressive disorder and PTSD. The improved pharmacokinetic profile could provide a competitive advantage in these large markets where current lithium treatments face significant limitations due to safety concerns.

However, as a micro-cap company with a market cap of just $6.7M, executing multiple Phase II trials simultaneously will require significant capital. Investors should monitor the company's cash position and potential financing needs as these trials progress.

Presentation Topic is the Pharmacokinetics of AL001, a Lithium Salicylate/L-Proline Co-crystal, as a Potentially Beneficial Lithium Sparing Treatment for Bipolar Disorder Type 1, Alzheimer’s Disease, Major Depressive Disorder and Post-Traumatic Stress Disorder

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 it will have a poster presentation at the Society of Toxicology (“SOT”) Annual Meeting and ToxExpo, being held from March 16-20, 2025, in Orlando, Florida.

“Our poster presentation at SOT in 2025 with data from our non-clinical study: Comparing Brain and Plasma Lithium Exposures between AL001 and Lithium Carbonate in Alzheimer’s Transgenic Mice, demonstrates the potential of AL001 to enhance brain-specific lithium delivery while minimizing systemic exposure in an Alzheimer’s disease mouse model, guiding development of enhanced lithium effectiveness and safety in human diseases,” said Stephan Jackman, Chief Executive Officer of Alzamend. “Following successful results from this study and our Phase I and IIA trials, AL001 is positioned for five Phase II trials in partnership with Massachusetts General Hospital in 2025. These trials aim to redefine lithium therapy across neurodegenerative and neuropsychiatric conditions by leveraging a lower-dose, high-efficacy approach anticipated to qualify for the U.S. Food and Administration 505(b)(2) approval pathway.”

Abstract 3266/H393 – Poster presentation:
Title: Pharmacokinetics of AL001, Lithium Salicylate/L-Proline Co-crystal: A Potentially Beneficial Lithium Sparing Treatment for Bipolar Disorder Type 1 (BD1), Alzheimer’s Disease (AD), Major Depressive Disorder (MDD) and Post-traumatic Stress Disorder (PTSD)
Session Title: Pharmaceutical Safety and Drug Discovery
Session Date and Time: Monday, March 17, 2025; 9:15AM ET – 11:45AM ET
Session Location: Orange County Convention Center, ToxExpo Hall
Presenting Author: Darrell Sawmiller, Ph.D, Assistant Professor, Center of Excellence for Aging & Brain Repair, University of South Florida, Tampa, FL, USA

Summary: No Undue Adverse Effects: Both treatments had no negative impact on the mice's body weight or clinical signs during the treatment period. Reduced Systemic Exposure: AL001 showed lower plasma lithium levels than lithium carbonate, reducing the risk of adverse systemic effects, suggesting an expansion for safety of lithium’s therapeutic index. Enhanced Brain Penetration: AL001 showed consistently higher lithium concentrations in brain tissues, particularly at lower doses, compared to lithium carbonate. Targeted Brain Structures: The study found that different brain regions absorb and retain lithium differently. This means treatments can potentially be tailored to target specific brain areas, allowing for more precise treatment of various brain-related conditions when applied in human studies.

Further information can be found at https://www.toxicology.org/events/am/AM2025/index.asp.

About AL001 Non-Clinical Study

The study involved administering AL001, a good manufacturing practices-quality active pharmaceutical ingredient (“API”) to 5XFAD mice, a recognized model for Alzheimer’s research, to compare its effects against lithium carbonate, a U.S. Food and Drug Administration approved and marketed API. Mice received either high or low doses scaled to humans of both AL001 and lithium carbonate over a 14-day period to observe pharmacokinetic steady-state drug conditions. On the 15th day, the mice were analyzed to assess how the treatments affected lithium concentrations in different brain regions and in their plasma. The results mentioned in the summary highlight the potential clinical advantages of AL001 for conditions like Alzheimer’s, BD, MDD and PTSD at low doses. By reducing the systemic burden, AL001 could lessen the risk of side effects such as thyroid and kidney complications often associated with extant lithium therapies. This positions AL001 as a promising candidate for safer long-term treatment options, without the need for routine blood lithium monitoring. This innovation is specifically designed to address the needs of fragile populations, such as elderly and Alzheimer’s patients, by offering a potentially more efficient and safer alternative to existing treatments.

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. 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/20241218800562/en/

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

Source: Alzamend Neuro, Inc.

FAQ

What are the key findings of ALZN's AL001 preclinical studies in 2025?

The studies showed AL001 achieved higher brain lithium concentrations at lower doses compared to lithium carbonate, with reduced systemic exposure and no adverse effects in mice.

How many Phase II trials is ALZN planning for AL001 in 2025?

Alzamend Neuro is planning five Phase II trials in partnership with Massachusetts General Hospital in 2025.

What conditions will ALZN's AL001 target in clinical trials?

AL001 targets Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder.

What regulatory pathway is ALZN pursuing for AL001?

Alzamend Neuro is pursuing the FDA 505(b)(2) approval pathway for AL001.

When and where will ALZN present their AL001 data in 2025?

The data will be presented at the Society of Toxicology Annual Meeting and ToxExpo in Orlando, Florida, on March 17, 2025, from 9:15 AM to 11:45 AM ET.