Tiziana Life Sciences Announces FDA IND Clearance of Intranasal Foralumab for the Treatment of Alzheimer’s Disease

• Foralumab to advance into Phase 2 human clinical trials using the world’s only fully human intranasal anti-CD3 monoclonal antibody
• Trial to be overseen by Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System

NEW YORK, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for intranasal foralumab to be studied in Alzheimer's disease. Foralumab could be a potentially groundbreaking treatment for Alzheimer’s disease, given it targets the disease’s underlying pathology by addressing the resulting neuroinflammation caused by the accumulation of toxic proteins in the brain.

Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences, stated, "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, the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, added "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."