Tiziana Life Sciences announces the submission of its seventh annual Development Safety Update Report (DSUR) to the US Food and Drug Administration (FDA). This DSUR reports no drug-related serious adverse events after a cumulative exposure of 37.4 patient-years, highlighting the safety and tolerability data profile of intranasal foralumab in treating neuroinflammatory diseases, including non-active Secondary Progressive Multiple Sclerosis (naSPMS), multiple system atrophy and Alzheimer’s disease.

“The FDA’s 23 December, 2025 complete response letter denying approval of Sanofi’s tolebrutinib for nrSPMS, based on toxicity, highlights the need for a safe therapy for untreated neuroinflammatory disorders. We have seen 37.4 patient-years of cumulative foralumab exposure with no study drug-related serious adverse events, a milestone that reinforces the safety of our intranasal approach. Our phase II foralumab trial in naSPMS will read out in 2026,” said Ivor Elrifi, Chief Executive Officer, Tiziana.

Key highlights from the submission include data from multiple clinical and expanded access programmes. Under the Expanded Access Programme, 14 non-active SPMS patients received intranasal foralumab at a dose of 50 micrograms administered six days per three-week cycle, with treatment durations ranging from 23 weeks to 3.5 years, contributing a total of 30.7 patient years of exposure. In the TILS-021 randomised trial and the TILS-022 open-label extension, patients with non-active SPMS were treated with foralumab at 50 or 100 microgram doses, accounting for approximately 5.2 patient-years of exposure. In addition, a single-patient expanded access programme for Alzheimer’s disease (IND 172400) included one patient with moderate disease who completed 28 weeks of treatment at 50 micrograms, adding 0.5 patient-years of exposure.

This cumulative exposure of 37.4 patient years underscores the significant clinical experience gained with intranasal foralumab in CNS indications. Notably, no serious adverse events have been attributed to the study drug in these nasal administration studies. Adverse events reported during the period were consistent in type and frequency with previous reports. No new risks were identified that necessitated significant protocol modifications.

The safety profile of intranasal foralumab aligns with prior studies of foralumab administered intravenously in healthy volunteers, patients with Crohn’s disease and kidney transplant recipients. Unlike IV administration, which has been linked to infusion-related reactions seen with other anti-CD3 monoclonal antibodies, nasal delivery of foralumab has shown vastly improved tolerability, with no such issues observed. No new actions are required to address foralumab safety based on this update.