Tiziana reported Phase 2 PET imaging data showing reduced neuroinflammation in a third multiple system atrophy patient treated with intranasal foralumab
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Tiziana Life Sciences has reported quantitative positron emission tomography (PET) imaging results from the third patient with multiple system atrophy (MSA) who completed treatment in its ongoing Phase 2 clinical trial (NCT06868628) evaluating intranasal foralumab. The latest findings showed reductions in neuroinflammatory activity across brain regions commonly affected by MSA, closely matching results previously observed in the first two treated patients.
Quantitative PET analysis demonstrated up to a 34% reduction in standardized uptake value (SUV) and a 26% reduction in standardized uptake value ratio (SUVR) within the basal ganglia and cerebellar white matter, two regions heavily involved in MSA pathology. Earlier patients achieved reductions of approximately 35% in SUV and 24% in SUVR, indicating reproducible imaging responses across treated participants.
Intranasal Anti-CD3 Therapy Targets Neuroinflammation
Foralumab is a fully human anti-CD3 monoclonal antibody administered intranasally to induce immune tolerance through mucosal immune pathways. Unlike conventional systemic anti-CD3 therapies, the investigational treatment aims to modulate immune responses while minimizing systemic toxicities. By promoting regulatory T-cell activity, the therapy is intended to reduce chronic neuroinflammation, a key contributor to neurodegenerative diseases.
Multiple system atrophy is a rare, rapidly progressive neurodegenerative disorder characterized by autonomic failure, parkinsonism, and cerebellar dysfunction. Patients experience worsening disability over time, and no disease-modifying therapies have been approved, leaving treatment focused largely on symptom management.
PET Imaging Findings Support Biological Activity
The Phase 2 study is evaluating whether intranasal foralumab can reduce neuroinflammation in patients with MSA using quantitative PET imaging. Comparisons of scans obtained before and after treatment demonstrated lower radiotracer uptake in disease-relevant brain regions, suggesting decreased inflammatory activity following therapy.
According to Tarun Singhal, MBBS, MD, MBA, Founding Director of the NeuroPET Program at the Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital and Associate Professor of Neurology at Harvard Medical School, the third patient’s imaging findings closely mirrored those seen in the first two treated participants. He noted that the reproducible reductions strengthen imaging evidence supporting the biological activity of intranasal foralumab in reducing neuroinflammation, while emphasizing that correlations with clinical outcomes and confirmation using additional quantitative methods remain necessary.
Company Highlights Expanding Evidence Across Neurodegenerative Diseases
Tiziana Chief Executive Officer Ivor Elrifi said the consistent PET imaging results from a third patient reinforce confidence in the therapeutic potential of intranasal foralumab. He noted that the findings build on earlier observations in MSA as well as previous studies in non-active secondary progressive multiple sclerosis (na-SPMS) and moderate Alzheimer’s disease.
Beyond MSA, intranasal foralumab has been administered to 14 patients through an open-label Expanded Access Program in non-active secondary progressive multiple sclerosis (NCT06802328), where all participants demonstrated either disease stability or improvement within six months. The therapy is also being evaluated in a randomized, double-blind, placebo-controlled Phase 2a trial in na-SPMS (NCT06292923).
Future Development
Tiziana plans to continue enrolling and evaluating additional patients with MSA to determine whether the PET imaging findings remain consistent across a larger population and to further characterize the therapy’s effect on neuroinflammation. As the only fully human anti-CD3 monoclonal antibody currently in clinical development, intranasal foralumab represents a differentiated immunomodulatory approach that could expand treatment options for neuroinflammatory and neurodegenerative disorders if ongoing clinical studies confirm its therapeutic benefit.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.