Pharma Focus America

Tiziana Life Sciences Obtains FDA IND Clearance for Intranasal Foralumab in Alzheimer's Disease Treatment

Wednesday, August 16, 2023

Tiziana Life Sciences Ltd. (Nasdaq: TLSA) recently made an important announcement regarding its biotechnology efforts. The company, which specializes in pioneering immunomodulation treatments using unique drug delivery methods, shared news about the U.S. Food and Drug Administration (FDA) granting clearance for its Investigational New Drug (IND) application for intranasal foralumab. This clearance paves the way for the study of foralumab's potential in treating Alzheimer's disease. The approach of targeting the core pathology of Alzheimer's by addressing neuroinflammation resulting from the accumulation of harmful brain proteins adds significant promise to the treatment.

Gabriele Cerrone, the Chairman, acting CEO, and founder of Tiziana Life Sciences, emphasized the importance of this achievement, stating, "The IND clearance is a significant milestone for Tiziana that highlights the strength and the therapeutic potential of foralumab. We are deeply committed to advancing the field of neurodegenerative diseases and bringing much-needed relief to patients suffering from Alzheimer's with a novel therapeutic approach. We are thrilled to have reached this critical juncture and are eager to move forward with the necessary trials to evaluate the effectiveness of foralumab in Alzheimer's disease in combination with an FDA approved therapy or as a single agent."

Professor Howard L. Weiner, a distinguished figure in neurology, also added his perspective, saying, "The IND clearance is a significant step forward in the fight against Alzheimer's disease. Foralumab shows great promise in targeting the pathological hallmarks of the disease, and I am optimistic about its potential to offer a breakthrough treatment option for patients suffering from this devastating condition. I look forward to witnessing the progress of this important therapy."

Foralumab functions by interacting with activated T cells, integral to the inflammatory process. As the only fully human anti-CD3 monoclonal antibody (mAb), it binds to the T cell receptor, acting to reduce inflammation by regulating T cell function. This mechanism suppresses effector attributes across multiple immune cell subsets, as observed in instances such as COVID-19, multiple sclerosis, and healthy subjects. Anticipated for the third quarter of 2023 are Phase 2 trials involving intranasal foralumab, targeting non-active secondary progressive multiple sclerosis (SPMS) patients. This approach, utilizing nasal anti-CD3 mAb for immunomodulation, introduces a novel pathway for addressing various inflammatory conditions.

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