Tiziana Life Sciences has shared positive three-month neuroimaging scores in non-active secondary progressive multiple sclerosis (na-SPMS) patients receiving intranasal foralumab.
Affecting approximately 2.8 million people worldwide, MS is a neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body.
SPMS is a stage of MS that usually follows relapsing remitting MS. With this form of the disease, the patient’s disability gets steadily worse and relapses become unlikely.
Tiziana’s foralumab, an investigational fully-human anti-CD3 monoclonal antibody, is designed to bind to the T cell receptor and dampen inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets.
New data from the open-label intermediate-sized expanded access (ISPPEA) programme presented at this year’s American Academy of Neurology meeting demonstrated improvements in White Matter Z-scores, used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain, in intranasal foralumab-treated na-SPMS patients.
Reductions of 28% to 48% were observed, indicating improvement in five out of six patients, as well as a 36% median reduction in White Matter Z-scores compared to baseline.
Gabriele Cerrone, chairman, acting chief executive officer and founder of Tiziana, said: “We are seeing this additional, encouraging evidence of intranasal foralumab’s effect after reporting that it attenuated microglial activation in na-SPMS patients with progression independent of relapse activity at three months…”
Cerrone added that a double-blind, placebo-controlled, dose-ranging study of intranasal foralumab in na-SPMS is “currently underway”.
The presentation came just days after Tiziana reported additional positive clinical results from its ISPPEA programme, with 70% of foralumab-treated na-SPMS patients showing an improvement in fatigue after six months of follow-up.
Cerrone said at the time of the announcement: “Fatigue is a pervasive and challenging symptom for individuals living with MS, impacting their daily lives in profound ways.
“The clinically meaningful improvement in fatigue levels seen in seven out of ten patients, as well as the stabilisation or improvements in other key clinical outcome measures that were seen in all patients, underscores the potential of Tiziana’s investigational therapy to address this critical unmet need.”