Tiziana Life Sciences announces results from study of nasal foralumab

Tiziana Life Sciences (TLSA) announced promising results from an open-label clinical study evaluating nasal foralumab, the world’s only fully human anti-CD3 monoclonal antibody administered intranasally, for the treatment of non-active secondary progressive multiple sclerosis. This comprehensive study demonstrated that nasal foralumab was safe, induced potent regulatory immune responses, reduced microglial activation, and stabilized clinical progression in patients suffering from progression independent of relapse activity-a major unmet need in the treatment of MS, and a key disease endpoint for intranasal foralumab development. Study Highlights: All patients experienced stabilization of their Expanded Disability Status Scale scores; three of four patients that were treated continuously for 12 months showed improvement; Fatigue, a major symptom burden in MS, improved in six out of ten patients, as measured by the Modified Fatigue Impact Scale; Total MFIS scores correlated strongly with mGALP scores in the hippocampus at baseline; No new T2 lesions were observed on MRI; TSPO-PET imaging showed significant reductions in microglial activation at six months; Single-cell RNA sequencing revealed early and sustained changes in peripheral immune cells, including increased regulatory T cells and expression of TGFbeta across multiple cell types.