Tiziana Life Sciences Ltd. announced "first patient dosed" in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary- progressive multiple sclerosis (na-SPMS). Six investigational centers have been recruited for this double-blind, placebo-controlled trial, with up to 18 patients per treatment arm. The primary endpoint of the trial will be the change in microglial activation based on PET scans.

Clinical evaluations include the Expanded Disability Status Scale (EDSS),oL assessments, and the Modified Fatigue Impact Scale (MFIS), which assess parameters that are essential to a patient's everyday life. Novel immuno-biomarkers will be measured also and assessed for predictive relevance. Central review of PET scans and images is an integral component of this study.

Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby addressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects.

The non-active SPMS intranasal foralUMab Phase 2 trial dosed its first patient in December of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.