Tiziana’s Foralumab Cuts MSA Brain Inflammation Up to 35% SUV, 24% SUVR
Tiziana's Phase 2 trial in two MSA patients demonstrated up to 35% reduction in PET scan SUV and 24% lower SUVR in basal ganglia and cerebellar white matter after intranasal foralumab. This third reduction signal in MSA mirrors PET findings in secondary progressive multiple sclerosis and Alzheimer’s disease.
1. Phase 2 Trial Results in MSA
Tiziana initiated a Phase 2 clinical trial treating the first two MSA patients with intranasal foralumab, marking the third neurodegenerative indication under study. Investigators performed pre- and post-treatment PET imaging to quantify neuroinflammatory changes in brain regions affected by multiple system atrophy.
2. Quantitative PET Imaging Findings
Quantitative analysis revealed up to 35% reduction in standardized uptake value (SUV) and a 24% decrease in standardized uptake value ratio (SUVR) in basal ganglia and cerebellar white matter after dosing. These regions are critically involved in MSA pathology and showed marked declines in radiotracer uptake.
3. Foralumab's Mechanism and Prior Indications
Foralumab is a fully human anti-CD3 monoclonal antibody administered intranasally to induce mucosal tolerance and reduce neuroinflammation without systemic toxicities. This trial represents its third indication, following comparable PET scan improvements observed in non-active secondary progressive multiple sclerosis and moderate Alzheimer’s disease.
4. Next Steps and Development Plans
Tiziana plans to enroll additional MSA patients to further validate these early findings, aiming to characterize dose response and long-term effects on neuroinflammation. With no approved disease-modifying therapies for MSA, these data support potential future expansion into a rare neurodegenerative market.