Tiziana Reports 80% MS Patients Show Neuroimaging Improvement with Intranasal Foralumab

Tiziana Life Sciences, Ltd., a biotechnology company listed on Nasdaq under the ticker TLSA, has announced promising qualitative results from its Expanded Access Program for non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients treated with its intranasal foralumab for at least six months. The company's novel approach to drug delivery aims for breakthrough treatments in immunomodulation.

The study focused on ten na-SPMS patients who received intranasal foralumab over a six-month period. Findings revealed that eight out of the ten patients showed qualitative improvements in PET imaging, indicating a reduction in microglial activity. This data was confirmed by Dr. Tarun Singhal, a leading expert in PET imaging in neurologic diseases at Brigham and Women’s Hospital and an Associate Professor of Neurology at Harvard Medical School. Dr. Singhal noted that of the latest cohort of four patients, three exhibited reduced microglial PET signals, aligning with earlier observations in the first six patients.

The qualitative reductions in microglial activity suggest that intranasal foralumab effectively modulates T cell function, dampening inflammation across multiple immune cell subsets. These encouraging results are considered a significant step in the treatment of neuroinflammatory and neurodegenerative diseases like multiple sclerosis.

Tiziana Life Sciences is moving forward with its intranasal foralumab program. The U.S. Food and Drug Administration (FDA) has granted permission for an additional 20 patients to be enrolled in the Expanded Access Program, allowing for more comprehensive data collection and analysis. Furthermore, Tiziana has applied for FDA Orphan Drug Designation for foralumab in treating na-SPMS, which could offer additional support and incentives for the drug’s development.

Gabriele Cerrone, the Chairman and acting CEO of Tiziana Life Sciences, expressed his enthusiasm for the positive outcomes so far. He emphasized the importance of further quantitative analysis to solidify these findings and highlighted the company's commitment to advancing its clinical trials. The ongoing Phase 2a trial of intranasal foralumab, which started screening patients in November 2023, marks another critical milestone in the development of this treatment.

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) and represents a novel approach to immunomodulation. Unlike traditional intravenous (IV) delivery, intranasal administration of foralumab has shown potential advantages in efficacy, safety, and tolerability. This approach has demonstrated promising clinical responses not only in multiple sclerosis patients but also in individuals with COVID-19 and healthy subjects.

Tiziana Life Sciences aims to revolutionize immunotherapy through innovative drug delivery technologies. The company's patented technology for alternative immunotherapy routes is expected to support a broad range of applications, expanding its impact across various diseases.

The ongoing research and development efforts by Tiziana Life Sciences underscore the potential of intranasal foralumab to transform the treatment landscape for multiple sclerosis and other neuroinflammatory conditions. As the company continues to collect and analyze data, the medical community remains hopeful about the future implications of this groundbreaking therapy.

In summary, the initial results from Tiziana Life Sciences’ Expanded Access Program for intranasal foralumab are promising, showing significant qualitative improvements in PET imaging for na-SPMS patients. With additional patient enrollment and further quantitative studies, the company is well-positioned to advance its pioneering approach to treating neuroinflammatory diseases.