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Tiziana Life Sciences Announces Comprehensive Positive Results from Study of Nasal Foralumab in Patients with Multiple Sclerosis

Core Insights - Tiziana Life Sciences announced promising results from an open-label clinical study of intranasal foralumab for treating non-active secondary progressive multiple sclerosis (na-SPMS), demonstrating safety, regulatory immune response induction, and clinical progression stabilization [1][3][6] Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, particularly intranasal foralumab, the only fully human anti-CD3 monoclonal antibody in clinical development [10][9] Study Findings - The study showed that nasal foralumab was safe, reduced microglial activation, and stabilized clinical progression in patients with na-SPMS, addressing a significant unmet need in MS treatment [1][4][6] - All ten patients treated for a minimum of six months experienced stabilization of Expanded Disability Status Scale (EDSS) scores, with some showing improvement [7][6] - Significant reductions in microglial activation were observed at six months, with a p-value of less than 0.05 [6][7] Future Developments - Tiziana Life Sciences has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial to further evaluate the efficacy and safety of nasal foralumab, with top-line data expected by the end of 2025 [5][8] - The company is also exploring the potential of nasal foralumab in treating other conditions such as Alzheimer's Disease and ALS [8]