Alzamend Neuro, Inc. (Nasdaq: ALZN), a clinical-stage biopharmaceutical company, has partnered with QMENTA, a leading medical imaging AI company, to support its upcoming Phase II clinical trials of AL001, a novel lithium delivery formulation. The trials, set to take place at Massachusetts General Hospital, aim to explore the unique properties and potential benefits of AL001 in treating Alzheimer’s disease (AD), bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). QMENTA’s cloud-based platform will handle the management and analysis of medical imaging data, ensuring regulatory compliance and enhancing operational efficiency. This advanced AI solution is expected to optimize the imaging workflow across all five clinical studies, providing critical insights into AL001’s performance. AL001, a patented ionic cocrystal technology combining lithium, salicylate, and L-proline, is designed to deliver lithium more effectively to the brain while reducing systemic side effects. Previous mouse studies have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood. This could potentially eliminate the need for lithium therapeutic drug monitoring (TDM), a cumbersome process that involves frequent blood tests to maintain safe plasma lithium levels. Conventional lithium salts, known for their efficacy in treating manic episodes and maintaining BD, are limited by a narrow therapeutic window and require multiple daily doses to achieve and maintain therapeutic concentrations. AL001’s formulation promises to reduce the systemic burden, thereby minimizing risks associated with kidney and thyroid side effects, which are common with traditional lithium therapies. The Phase II clinical trials will begin with a study in healthy human subjects to establish a baseline and assess the safety and efficacy of AL001. Subsequent studies will focus on AD, BD, MDD, and PTSD patients. These trials are crucial for determining the optimal dosing and administration strategies for each condition, ultimately paving the way for safer and more effective treatments. Stephan Jackman, CEO of Alzamend Neuro, expressed his excitement about the partnership, emphasizing QMENTA’s expertise in AI-driven medical imaging. "QMENTA has developed a comprehensive platform that integrates advanced AI solutions for clinical trials," Jackman said. "Their support will be invaluable in managing our five Phase II studies of AL001 and setting the stage for future Phase III programs and broader clinical deployment." Vesna Prchkovska, CEO of QMENTA, shared her enthusiasm, stating, "We are honored to collaborate with Alzamend on this transformative work. The right imaging strategy combined with innovative compounds like AL001 can revolutionize the treatment of complex neurodegenerative diseases and psychiatric disorders. Our AI-driven technologies will help advance these safer and more effective treatments, making a significant impact on patient care." Alzamend Neuro’s pipeline includes two promising candidates: AL001 and ALZN002. ALZN002 is a second-generation active-immunity vaccine using a patented method with mutant-peptide sensitized cells to help the immune system combat AD by removing beta-amyloid from the brain. This approach aims to overcome the drawbacks of existing passive immunity antibodies, such as reduced dosing frequency and lower costs. The partnership with QMENTA underscores Alzamend’s commitment to leveraging cutting-edge technology to enhance the development and delivery of its therapeutic candidates. By integrating QMENTA’s AI capabilities, Alzamend hopes to streamline the clinical trial process, gather more accurate and meaningful data, and ultimately bring these novel treatments to market more efficiently. Industry analysts see this collaboration as a significant step towards addressing the limitations of current lithium therapies. They anticipate that the successful demonstration of AL001’s effectiveness and safety could lead to broader adoption and significant improvements in the management of AD, BD, MDD, and PTSD. Alzamend Neuro, founded with the mission to rapidly develop and market safe and effective treatments, has licensed both its drug candidates from the University of South Florida Research Foundation, Inc. under royalty-bearing exclusive worldwide licenses. The company’s focus on innovation and strategic partnerships positions it as a promising player in the field of neurodegenerative and psychiatric disorders, with the potential to make a substantial impact on patient care and quality of life.