Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients

Multiple sclerosis (MS) is a common autoimmune disorder affecting young adults, driven by an aberrant T cell response against central nervous system (CNS) antigens. Epidemiologic studies show that approximately 50% of patients are classified as having relapsing-remitting multiple sclerosis (RRMS), while about 35% have SPMS and the remaining 15% have primary progressive MS (PPMS). Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. It is hypothesized that nasal Foralumab will slow disability accumulation and microglial activation measured by PET imaging in non-active SPMS. Patients will be dosed in 3-week cycles, with Foralumab dosing on Days 1, 3 and 5 of the first and second weeks, followed by a "rest week". This study will assess the safety of nasal Foralumab given over 6 months to non-active secondary progressive MS patients who have failed currently available treatments including the standard of care therapy, Ocrevus (ocrelizumab).