Tiziana Submits 37.4 Patient-Years Safety Report for Foralumab, Highlighting Safety Profile
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 29 2025
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Source: Globenewswire
- Safety Milestone: Tiziana's seventh Development Safety Update Report reveals no serious adverse events after 37.4 patient-years of exposure to foralumab, underscoring its safety in treating neuroinflammatory diseases and enhancing the company's competitive edge in biopharmaceuticals.
- Clinical Experience Accumulation: In the Expanded Access Program, 14 naSPMS patients received foralumab, contributing 30.7 patient-years of exposure, demonstrating the drug's potential and efficacy in clinical applications.
- Treatment Demand Highlighted: The FDA's denial of Sanofi's tolebrutinib application emphasizes the urgent need for safe therapies, positioning Tiziana's findings as a new treatment option that may attract increased investor interest.
- Future Trial Outlook: Tiziana's Phase 2 trial is set to read out in 2026, and if successful, will further solidify its leadership in neurodegenerative disease treatment, driving long-term growth for the company.
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About TLSA
Tiziana Life Sciences Ltd. is a United Kingdom-based clinical-stage biotechnology company that specializes in developing transformative therapies for neurodegenerative and neuroinflammatory diseases. The Company’s clinical pipeline includes drug assets for secondary progressive multiple sclerosis, Alzheimer’s, and ALS. Its lead immunotherapeutic candidate, Foralumab (TZLS-401), is being developed for Non-Active Secondary Progressive Multiple Sclerosis, Alzheimer’s and other CNS indications. Its Anti-IL-6R mAb (TZLS-501), a fully human mAb, binds to both membrane-bound and soluble forms of IL-6R, an inflammatory cytokine driving chronic inflammation associated with autoimmune and cancer, reducing circulating levels of the IL-6 cytokine. Its oncology product candidate, Milciclib, is a combination therapy for the treatment of refractory solid tumors (being cancers which are non-responsive or become resistant to treatment), especially non-small cell lung cancer (NSCLC).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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.
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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.
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