Tiziana Files Annual Safety Report for Intranasal Foralumab with FDA

Core Viewpoint - Tiziana Life Sciences has submitted its seventh annual Development Safety Update Report (DSUR) to the FDA, reporting no drug-related serious adverse events for its lead candidate, intranasal foralumab, after 37.4 patient-years of cumulative exposure, emphasizing its safety profile in treating neuroinflammatory diseases [1][2][3]. Group 1: Safety and Efficacy of Foralumab - The DSUR indicates that there have been no serious adverse events attributed to intranasal foralumab, reinforcing its safety in clinical trials [2][3]. - The cumulative exposure of 37.4 patient-years demonstrates significant clinical experience with intranasal foralumab in central nervous system (CNS) indications [3][4]. - Adverse events reported were consistent with previous studies, and no new risks were identified that would require protocol modifications [3][4]. Group 2: Comparison with Other Treatments - The safety profile of intranasal foralumab aligns with prior studies of intravenous foralumab, which had been associated with infusion-related reactions, unlike the nasal delivery method that showed improved tolerability [4][10]. - The recent FDA denial of Sanofi's tolebrutinib for non-active secondary progressive multiple sclerosis (naSPMS) due to toxicity highlights the need for safer therapies in the neuroinflammatory disorder space [2][8]. Group 3: Clinical Development and Future Trials - Tiziana is conducting a Phase 2 trial of foralumab in naSPMS, with results expected in 2026 [2][5]. - Currently, 14 patients with naSPMS have been treated in an Expanded Access Program, showing either improvement or stability of disease within six months [5][9]. - Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development, representing a novel approach to treating neuroinflammatory and neurodegenerative diseases [6][10].