Tiziana Life Sciences Publishes Foralumab Study Results
Tiziana Life Sciences announces the peer-reviewed publication of its open-label study in patients with non-active secondary progressive multiple sclerosis in Neurology Neuroimmunology & Neuroinflammation, a prestigious journal of the American Academy of Neurology.The publication, titled "Nasal Foralumab for the Treatment of Progression Independent of Relapses in Patients with Non-active Secondary Progressive Multiple Sclerosis," details the comprehensive positive results previously announced by the Company on May 6, 2025. This marks the first study to integrate TSPO-PET imaging, proteomics, and clinical assessments in na-SPMS, highlighting nasal foralumab's novel mechanism in addressing progression independent of relapse activity-a critical unmet need in multiple sclerosis treatment. Key Study Highlights: Ten patients with na-SPMS, progressing despite prior B-cell therapies, received nasal foralumab for at least six months. No serious or severe treatment-related adverse events occurred. All patients showed stabilization of Expanded Disability Status Scale scores; three of four treated for 12 months demonstrated improvement. Fatigue improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale-a vital quality-of-life measure for MS patients. No new T2 lesions appeared on MRI. TSPO-PET imaging revealed significant reductions in microglial activation at three and six months. Single-cell RNA sequencing demonstrated sustained increases in regulatory T cells and TGFbeta expression, supporting induction of regulatory immunity.
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Tiziana Life Sciences Publishes Intranasal Foralumab Study, Highlighting Efficacy Potential
- Clinical Study Results: Tiziana Life Sciences' intranasal foralumab clinical study has been published in Neurology Neuroimmunology & Neuroinflammation, confirming the therapy's potential for non-active secondary progressive multiple sclerosis patients, particularly those worsening despite prior treatments.
- Study Design and Findings: The open-label trial evaluated intranasal foralumab in 10 na-SPMS patients, showing improvements in clinical symptoms for several patients, favorable biomarker shifts indicating reduced inflammation, and a well-tolerated safety profile with no major concerns reported.
- Advantages of Delivery Route: The intranasal delivery method aims to engage the immune system through mucosal pathways, potentially offering a safer and more targeted treatment option compared to systemic immunosuppression, which Tiziana positions as a differentiator in autoimmune disease therapy.
- Future Development Plans: With peer-reviewed validation, Tiziana plans to advance intranasal foralumab through further clinical development, expecting top-line data from an ongoing randomized, double-blind, placebo-controlled Phase 2 trial in na-SPMS in the first half of 2026, while exploring broader applications in neuroinflammatory and autoimmune conditions.
Tiziana Life Sciences Publishes Positive Study Results for Intranasal Foralumab in MS Patients
- Publication of Results: Tiziana Life Sciences has published an open-label study on intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS) in the journal Neurology Neuroimmunology & Neuroinflammation, marking a significant milestone that highlights the therapy's potential in treatment.
- Positive Patient Outcomes: Among ten patients treated with nasal foralumab, all showed stabilization of Expanded Disability Status Scale (EDSS) scores, with three out of four patients treated for 12 months demonstrating improvement, indicating the therapy's clinical effectiveness.
- High Safety Profile: No serious or severe treatment-related adverse events were reported during the study, further validating the safety of nasal foralumab and enhancing its appeal as a treatment option for multiple sclerosis.
- Biomarker Discoveries: TSPO-PET imaging revealed significant reductions in microglial activation, and single-cell RNA sequencing demonstrated sustained increases in regulatory T cells and TGFβ expression, supporting the unique immunomodulatory mechanism of nasal foralumab and offering new hope for patients.
