GlobeNewswire·Dec 29, 2025, 8:00 AM ET

Tiziana Files Annual Safety Report for Intranasal Foralumab with FDA

Tiziana Life Sciences submitted its seventh annual Development Safety Update Report (DSUR) to the FDA covering the period from September 21, 2024, to September 2, 2025.
The report highlights a cumulative exposure of 37.4 patient-years for intranasal foralumab with zero drug-related serious adverse events.
The DSUR data includes 30.7 patient-years from an Expanded Access Program for 14 non-active secondary progressive multiple sclerosis (naSPMS) patients, 5.2 patient-years from TILS-021 & TILS-022 trials, & 0.5 patient-years from a single Alzheimer's Disease patient.
CEO Ivor Elrifi noted the safety findings contrast with the FDA's recent denial of Sanofi's tolebrutinib for nrSPMS due to toxicity concerns.
Unlike intravenous anti-CD3 therapies, the intranasal route for foralumab showed vastly improved tolerability with no infusion-related reactions.
No new safety risks were identified during the reporting period & no protocol modifications were deemed necessary.
Foralumab is currently the only fully human anti-CD3 monoclonal antibody in clinical development & is being evaluated for naSPMS, multiple system atrophy, & Alzheimer's Disease.
Tiziana's Phase 2 foralumab trial in naSPMS is expected to report results in 2026.