Tiziana Life Sciences Reports Positive Nasal Foralumab Study Results in Multiple Sclerosis

Tiziana Life Sciences, a biotechnology company focused on developing innovative immunomodulation therapies, has announced promising results from a clinical study involving their lead candidate, nasal foralumab. This novel treatment is a fully human anti-CD3 monoclonal antibody designed for intranasal delivery, and it showed significant promise in addressing non-active secondary progressive multiple sclerosis (na-SPMS), a condition with limited current treatment options.

The open-label study evaluated the safety and efficacy of nasal foralumab in ten patients with na-SPMS, who continued to show disease progression despite having received B-cell therapy. Over a minimum duration of six months, the treatment exhibited a robust safety profile with no severe adverse effects. Importantly, all participating patients experienced stabilization of their Expanded Disability Status Scale (EDSS) scores. Furthermore, among the four patients who received continuous treatment for 12 months, three displayed marked improvements.

A key focus of the study was the impact of nasal foralumab on fatigue, a significant quality of life measure for multiple sclerosis patients. Using the Modified Fatigue Impact Scale (MFIS), six out of ten patients demonstrated improvements in fatigue levels. This improvement correlated strongly with baseline mGALP scores in the hippocampus. Additionally, magnetic resonance imaging (MRI) showed no new T2 lesions, supporting the treatment's potential in halting disease progression.

One of the study's significant findings was the reduction in microglial activation, as evidenced by TSPO-PET imaging, which showed significant decreases in microglial activity after six months of treatment. This reduction is vital as microglial activation plays a central role in the inflammation characteristic of progressive MS forms. Moreover, single-cell RNA sequencing indicated early and sustained changes in peripheral immune cells, with an increase in regulatory T cells and TGFβ expression across different cell types, highlighting a shift towards regulatory immune responses.

Leading the study, Dr. Tanuja Chitnis, a professor of neurology at Harvard Medical School, emphasized the importance of these findings for patients with progressive MS, who face limited therapeutic options. Nasal foralumab offers a non-invasive treatment alternative that reduces harmful central nervous system inflammation without the systemic immunosuppression associated with traditional therapies.

Nasal foralumab works by engaging the mucosal immune system to promote regulatory immune responses, thereby diminishing central nervous system inflammation. This mechanism contrasts with existing treatments that primarily target B-cells and cell trafficking, which have limited impact on the progression occurring behind the blood-brain barrier. Previous studies in animal models have shown that nasal anti-CD3 can expand regulatory T cells, providing the scientific foundation for this human study.

Following these encouraging findings, Tiziana Life Sciences has initiated a Phase 2 clinical trial to further evaluate the efficacy and safety of nasal foralumab in a larger cohort of patients with na-SPMS. This trial, which is randomized, double-blind, and placebo-controlled, aims to provide more comprehensive data and is expected to deliver top-line results by the end of 2025. Tiziana's CEO, Ivor Elrifi, expressed excitement over the potential of nasal foralumab to transform the treatment landscape for progressive MS and indicated plans to explore its application in other neurodegenerative diseases like Alzheimer's and ALS.

Overall, the study underscores the potential of nasal foralumab as a groundbreaking treatment for progressive MS, offering hope for improved patient outcomes through innovative delivery and immunomodulation strategies.