Tiziana Life Sciences Ltd (NASDAQ:TLSA) reported PET imaging results from two patients in a Phase 2 Multiple System Atrophy trial showing up to 35% and 24% reductions in brain inflammation markers following intranasal foralumab treatment.
The reductions were observed in areas including the basal ganglia and cerebellar white matter, regions known to be involved in the neurodegenerative processes underlying MSA, a rare, progressive disorder for which no approved disease-modifying treatments currently exist.
The results mark the third indication showing PET-scan inflammation reductions with intranasal foralumab, following earlier findings in secondary progressive multiple sclerosis and Alzheimer's disease.
"These early PET imaging findings provide quantitative evidence supporting the biological activity of intranasal foralumab in patients with MSA," said Tarun Singhal, founding director of the NeuroPET Program at the Ann Romney Center for Neurologic Diseases, Brigham and Women's Hospital. "Based on the available data, these appear to be robust quantitative findings and are comparable to results previously observed in patients with multiple sclerosis treated with intranasal foralumab, although there are methodological differences."
Tiziana CEO Ivor Elrifi said the MSA data further highlights the potential of the therapy to address neuroinflammation across multiple neurodegenerative conditions with high unmet need.
Intranasal foralumab is a fully human anti-CD3 monoclonal antibody designed to modulate the immune system through mucosal tolerance mechanisms and reduce inflammation without the systemic toxicities associated with traditional anti-CD3 therapies. It is currently the only fully human anti-CD3 monoclonal antibody in clinical development.
Tiziana said it plans to continue evaluating the therapy in additional MSA patients to further validate the early findings.