Biopharmaceutical Company Partners With General Hospital For Alzheimer's Trial
Biopharmaceutical Company Partners With General Hospital For Alzheimer's Trial
Alzamend Neuro Partners with Massachusetts General Hospital for Phase II Trial of AL001 in Alzheimer's Patients
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Alzamend Neuro, Inc. (Nasdaq: ALZN), a clinical-stage biopharmaceutical company, has announced an exciting partnership with Massachusetts General Hospital (Mass General) to conduct a Phase II clinical trial of AL001 for the treatment of Alzheimer’s disease. This collaboration aims to explore the potential benefits of AL001, a novel lithium-based therapeutic product, compared to existing lithium salts.
Alzamend Neuro and Mass General
Alzamend Neuro is dedicated to developing innovative treatments for a range of neurological and psychiatric conditions, including Alzheimer’s disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). Their focus is on creating novel products that offer improved safety and effectiveness compared to current treatment options. Massachusetts General Hospital is renowned for its extensive clinical education and research programs, being the original and largest clinical education and research facility affiliated with Harvard Medical School. It houses the world's largest hospital-based research program, making it an ideal partner for conducting advanced clinical trials.
The primary objective of this Phase II trial is to compare the effects of AL001 with currently marketed lithium salts in patients with Alzheimer’s disease. By examining the lithium content in the brain and brain structures, researchers aim to identify the optimal dose of AL001 that is both safe and effective. A cohort of healthy subjects will also be studied to provide comparative plasma and brain pharmacokinetics data.
Dr. Ovidiu Andronesi, MD, PhD, will serve as the principal investigator for this study. Dr. Andronesi is an Associate Professor of Radiology at Harvard University and the Director of Multinuclear Metabolic Imaging at the Martinos Center for Biomedical Imaging within the Department of Radiology at Massachusetts General Hospital.
Study Objectives and Methodology
One of the key aspects of this trial is to assess the increase in lithium levels within the brain and its structures when patients are treated with AL001 compared to a commonly marketed lithium salt. This examination will help determine the minimum dose necessary to achieve the same level of effectiveness and safety as established lithium treatments. Alzamend hopes that the outcomes of this study will assist in meeting the regulatory safety standards required through the Section 505(b)(2) pathway for approval by the U.S. Food and Drug Administration (FDA). This pathway is specifically designed for new formulations or delivery systems of an already approved drug, providing a streamlined approach to obtaining regulatory approval.
Prior to this Phase II trial, Alzamend successfully completed a Phase IIA multiple ascending dose clinical trial. In this earlier trial, the company identified a maximum tolerated dose (MTD) for AL001, as determined by an independent safety review committee. This dose, equivalent to 240 mg of lithium carbonate taken three times daily, was deemed unlikely to require lithium therapeutic drug monitoring (TDM).
The MTD established in the Phase IIA trial was carefully designed to mitigate risks for fragile populations, such as those with Alzheimer’s disease. This is crucial as patients with Alzheimer’s often have other health complications that can make them more vulnerable to side effects from medications.
Potential Impact on Alzheimer’s Treatment
If successful, the Phase II trial could pave the way for the development of a next-generation lithium product with an improved safety profile and enhanced biodistribution in the brain. Such a product would represent a significant advancement over current lithium-based treatments and could have a profound impact on the lives of the more than six million Americans living with Alzheimer’s disease.
Stephan Jackman, Chief Executive Officer of Alzamend, expressed his enthusiasm about the partnership and the potential benefits of AL001: “We are elated to partner with Mass General and Dr. Andronesi in this pivotal study for our lead therapeutic candidate AL001. 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 6+ million Americans afflicted with Alzheimer’s. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”
The Phase II clinical trial of AL001 holds promise for improving the quality of life for millions of individuals affected by this debilitating condition. By leveraging the expertise of Mass General and the innovative approach of Alzamend, there is hope for a new era in Alzheimer’s treatment.
Disclaimer: The information provided in this article is for educational purposes only and should not be considered as medical advice. Always consult with a healthcare professional before making any decisions related to medical treatments.
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