TLSA · Tiziana Life Sciences Ltd

Tiziana Life Sciences announced initial quantitative PET imaging results from the first two patients in its Phase 2 clinical trial of intranasal foralumab for Multiple System Atrophy (MSA), revealing significant reductions in neuroinflammatory activity. Specifically, investigators observed up to approximately 35% reduction in standardized uptake value (SUV) and 24% reduction in standardized uptake value ratio (SUVR) in clinically relevant brain regions such as the basal ganglia, thalamus, and cerebellar white matter, which are key to MSA's neurodegenerative processes. These findings, described as robust by Tarun Singhal, M.D., from Brigham and Women’s Hospital, are comparable to prior results in multiple sclerosis patients despite methodological differences. CEO Ivor Elrifi highlighted this as the third indication—following non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease—where intranasal foralumab has shown marked PET scan inflammation reductions, underscoring its potential to address neuroinflammation across high-unmet-need neurodegenerative conditions. Foralumab, a fully human anti-CD3 monoclonal antibody, works via mucosal tolerance to modulate immunity without systemic toxicities. With no approved disease-modifying MSA treatments, these early data support ongoing evaluation in additional patients, positioning the therapy as a novel candidate in intranasal immunotherapy.