Tiziana Life Sciences, Ltd. (NASDAQ:TLSA) ("Tiziana"), a biotechnology company developing its lead candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces initial quantitative PET imaging results from the first two patients with Multiple System Atrophy (MSA) in the Phase 2 clinical trial treated with intranasal foralumab. This is the third indication that has shown a marked reduction in inflammation on PET scans following treatment with intranasal foralumab.

Quantitative analysis of PET scans demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment with intranasal foralumab. In the first two treated patients, investigators observed up to approximately 35% reduction in standardized uptake value (SUV) and approximately 24% reduction in standardized uptake value ratio (SUVR) in affected areas of the brain.

"These early PET imaging findings provide quantitative evidence supporting the biological activity of intranasal foralumab in patients with MSA," said Tarun Singhal, MBBS, M.D., Founding Director, NeuroPET Program, Ann Romney Center for Neurologic Diseases, Brigham and Women's Hospital, Mass General Brigham. "In the first two MSA patients we evaluated, we observed up to approximately 35% reduction in standardized uptake value and a 24% reduction in SUV ratio in the affected brain regions. We focused on the most severely affected, clinically relevant areas known to be involved in MSA. 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."

"This is the third indication that we have seen a marked reduction in inflammation on PET scans following treatment with intranasal foralumab," said Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences. "Building on the encouraging results previously reported in non-active secondary progressive multiple sclerosis and moderate Alzheimer's disease, these initial MSA data further highlight the potential of our therapy to meaningfully address neuroinflammation across multiple neurodegenerative conditions with high unmet need."

PET imaging comparisons conducted before and after treatment demonstrated marked reductions in radiotracer uptake across several disease-relevant brain regions. These findings suggest a reduction in neuroinflammatory activity following administration of intranasal foralumab.

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.

MSA is a rare, progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar ataxia. There are currently no approved disease-modifying treatments for the condition.

Tiziana plans to continue evaluating intranasal foralumab in additional patients to further validate these early findings and better characterize the therapy's potential to reduce neuroinflammation in MSA.