Tiziana Life Sciences Reports Initial PET Imaging Results in MSA Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 14 2026
0mins
Tiziana Life Sciences announced initial quantitative PET imaging results from the first two patients with Multiple System Atrophy in a Phase 2 clinical trial treated with intranasal foralumab. The company reported that quantitative analysis demonstrated reductions in inflammatory activity in clinically relevant brain regions known to be affected in MSA following treatment. In the first two treated patients, investigators observed up to approximately 35% reduction in standardized uptake value and approximately 24% reduction in standardized uptake value ratio in affected areas. "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, CEO.
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About TLSA
Tiziana Life Sciences Ltd. is a biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Its clinical pipeline includes drug assets for Non-Active Secondary Progressive Multiple Sclerosis, Multiple System Atrophy, Alzheimer’s, and Amyotrophic lateral sclerosis. 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. Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycinreceptor kinases and Src family kinases controlling cell growth and malignant progression of cancer.
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.
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- Favorable Safety Profile: Foralumab exhibited a favorable safety and tolerability profile, outperforming both placebo and standard-of-care drug tolebrutinib in Expanded Disability Status Scale (EDSS) and MFIS scores, further supporting its clinical application potential.
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See More
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See More
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See More
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See More
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See More
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See More
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- Clinical Data Update: Tiziana Life Sciences updated clinical data from its expanded access program for Foralumab, showing positive progress in treating non-active secondary progressive multiple sclerosis (na-SPMS), with 14 patients treated over 6 months demonstrating significant disability stabilization.
- Fatigue Improvement: Results indicate a 64% improvement in fatigue as measured by the Modified Fatigue Impact Scale (MFIS), reflecting not only the drug's efficacy but also its potential to enhance patients' quality of life, which is clinically significant.
- Favorable Safety Profile: Foralumab exhibited a favorable safety and tolerability profile, outperforming both placebo and standard-of-care drug tolebrutinib in Expanded Disability Status Scale (EDSS) and MFIS scores, further supporting its clinical application potential.
- Future Development Prospects: With FDA breakthrough therapy designation granted in 2024, the ongoing Phase 2a randomized double-blind trial will provide additional data for Foralumab's application in multiple sclerosis treatment, potentially creating significant market opportunities for the company.
See More
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- Trial Enrollment Completion: Tiziana Life Sciences has announced the completion of patient enrollment in its Phase 2 clinical trial for non-active Secondary Progressive Multiple Sclerosis (na-SPMS), involving 48 patients, marking a significant milestone in the development of its lead anti-CD3 monoclonal antibody, foralumab.
- Data Release Expectations: Topline data from the trial is anticipated to be released in late Q3 2026 and will be presented at the ACTRIMS and ECTRIMS meeting in October, providing critical evidence for the drug's market potential and efficacy.
- Open Label Extension Phase: Following the blinded phase, all participants will have the opportunity to receive foralumab during a six-month open label extension, designed to assess long-term safety and sustained benefits, thereby enhancing treatment options for patients.
- Innovative Delivery Method: As the only fully human anti-CD3 monoclonal antibody, foralumab utilizes an intranasal delivery method that directly targets the brain's immune mechanisms, showcasing its potential in treating neuroinflammatory and neurodegenerative diseases, which could transform existing treatment paradigms.
See More
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- Enhanced Drug Tolerance: Tiziana Life Sciences' study indicates that the intranasal foralumab for multiple sclerosis is well-tolerated in patients, with no new safety signals reported, suggesting sustained safety in clinical applications.
- Favorable Disease Stabilization: Among 14 patients with non-active secondary progressive multiple sclerosis, the analysis shows a favorable tendency toward disease stabilization, further supporting foralumab's potential efficacy in treatment.
- Significant Fatigue Improvement: The study found that 64% of subjects (9 out of 14) achieved at least a four-point improvement in fatigue levels, as measured by the Modified Fatigue Impact Scale Score, indicating foralumab's positive impact on patients' quality of life.
- Future Development Outlook: CEO Ivor Elrifi expressed satisfaction with the continued positive safety and clinical trend data from the Expanded Access Program and looks forward to advancing the program toward approval, demonstrating the company's confidence in future prospects.
See More
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- Strong Safety Profile: In the ongoing Expanded Access Program, Tiziana's foralumab demonstrated excellent tolerability in 14 patients with non-active Secondary Progressive Multiple Sclerosis, with no new safety signals identified, indicating its reliability for long-term treatment.
- Disability Stabilization Trend: Data from the Expanded Access Program show a favorable trend in disability stabilization, with a reduction in Confirmed Disability Progression events, suggesting the drug's potential in controlling disease progression and improving patients' quality of life.
- Significant Fatigue Improvement: 64% of patients achieved a clinically meaningful improvement of ≥4 points on the Modified Fatigue Impact Scale (MFIS), reflecting not only the drug's efficacy but also its potential to enhance patients' daily functioning and overall well-being.
- Promising Future Research: Tiziana's CEO noted that foralumab's unique mechanism may offer a new treatment paradigm for progressive forms of multiple sclerosis, with future studies aimed at further validating its clinical application potential and advancing the drug towards approval.
See More
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- 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.
See More
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.
See More
