Alzamend Neuro announces the initiation date of phase II

Atlanta, March 04, 2025 (Globe Newswire) – Alzamend Neuro, Inc. (Nasdaq: Alzn) (“”Alzamous”), A biopharmaceutical company in the clinical stage that focuses on developing new products for the treatment of Alzheimer's disease (”Alzheimer“), bipolar disorder (“BD“), Major Depressive Disorder (“MDD“) And post -traumatic stress disorder (” (“PTBS”), Today, his plans to initiate a highly expected clinical phase -II study by AL001 for the treatment of patients with BD announced that will probably begin in the third quarter of 2025. This study follows the successful completion of a head coil by Tesla Dynamic Coils B, a key component in the clinical study.

In cooperation with the Massachusetts General Hospital as a contractual research organization, Alzamend aims to examine the unique properties of AL001 and its effects on the lithium tax in the brain compared to marketed lithium salts. The study could shed light on the way in patients with BD by providing the targeted effectiveness of AL001 and reducing systemic side effects. Earlier studies on mice have shown that AL001 guarantees better brain absorption and at the same time maintained a lower lithium level in the blood and paving the way for more secure and efficient treatments.

By offering treatment that may remove the need for a lithium therapeutic agent monitoring (“TDM”), AL001 could revolutionize the care of patient populations in need of protection and improve treatment results. Lithium, which is known for its effectiveness as first-line therapy for manic episodes and the preservation in BD, has not been utilized for a long time due to the complexity of TDM. The current lithium salts of the US food and drug management (carbonate and citrate) are limited by a narrow therapeutic window that regularly requires TDM of the plasma lithium level and blood chemistry by a clinic to alleviate undesirable events. Since conventional lithium salts are eliminated relatively quickly, several administrations are required during the day to safely reach the therapeutic plasma concentrations. By reducing systemic stress, Alzamends Novel AL001 formulation could mean a large shift in administrative conditions such as BD by minimizing the risks associated with kidney and thyroid effects that are traditionally connected to lithium therapies.

“With AL001, we may be able to introduce the next generation lithium treatment that offers improved security, better brain stargeting and no TDM needy, which promises a leap from the current, stressful options,” said Stephan Jackman, Managing Director of Alzamend. “This progress may improve the lives of over 7 million Americans who suffer from BD by offering a more effective and user -friendly therapeutic option, which may redesign the current treatment paradigms and significantly improve the quality of life of the patients.”

About AL001

AL001 is a new lithium delivery system that has the potential to offer the advantages of marketed lithium salts and at the same time to alleviate or avoid toxicities associated with lithium. The results of the completed phase-IIA dose study by Alzamend in Alzheimer's patients and healthy subjects identified a maximum tolerated dose (“MTD”), As evaluated by an independent security inspection committee. This MTD is designed in such a way that it is unlikely that it needs TDM and provides lithium in a relatively modest but effective dose. AL001 is said to distribute lithium in the brain positively, which leads to a lower exposure of other body organs and an improved security profile compared to currently marketed lithium salts. This can serve to alleviate or avoid the adverse upper limit for the toxicity of marketed lithium salts that have limited their benefits for patients and prescribers.

About Alzamend Neuro

Alzamend Neuro is a biopharmaceutical company in the clinical stadium that focuses on the development of new products for the treatment of Alzheimer's, BD, MDD and PTBs. Our mission is to quickly 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 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, with which antibody products marketed by the approved passive immunity are intended to alleviate the disadvantages of the approved passive immunity, in particular by reducing the necessary frequency and costs for the dosage costs associated with antibody products. Both product candidates are licensed by the University of South Florida Research Foundation, Inc., according to the exclusive global licenses of the Kingdom.

Predicted statements

This press release contains “future -oriented statements” within the meaning of Section 27a of the Securities Act of 1933 in the changed version and section 21e of the Securities Exchange Act from 1934 in the changed version. These future -oriented statements generally include statements that are predictive and depend on future events or conditions or on words such as “faith”, “plans”, “anticipated,” projects “,” estimates “,” expected “,” intends “,” strategy “,” future “,” opportunities, “May”, “may”, “”, “”, “”, ” “,” “,” “,” “,” “,” should “,” “,” “,”, “,”, “,”, “,”, “,”, “,”, “,”, “”, “”, “”, “future statements. Subject to risks and uncertainties. Further information, including potential risk factors that could affect Alzamend's business and finance results, contains Alzamend in the US Securities and Exchange Commission. You can find all submissions at www.sec.gov and on the Alzamend website at www.alzamend.com.

Contacts:
Email: info@alzamend.com or by phone: 1-844-722-63333333

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