Tiziana Life Sciences Ltd. announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA). Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate shown to cause T regulatory (Treg) cell induction when dosed intranasally. At present, ten (10) na-SPMS patients have been dosed in an Intermediate-Sized Patient Population Expanded Access (ISPPEA) Program with clinically meaningful reduction in fatigue scores (MFIS) in 70% of patients, and stability of disease noted within six months in all ten patients.

In addition, intranasal foralumab is currently being studied in a Phase 2a, double-blind randomized, placebo-controlled, multicenter trial in patients with na-SPMS (NCT06292923). The Fast Track Designation request provided data from both animal models and clinical experience from the ISPPEA program. Foralumab would be the only intranasal monoclonal antibody designated as other Multiple Sclerosis monoclonal antibody therapies require intravenous or subcutaneous dosing.

Fast Track Designation, if granted will affirm the serious disease condition and progressive disability seen in na-SPMS, and also the unmet medical need, as no therapies are currently approved for na-SPMS.