Researchers are launching a clinical trial to test foralumab combined with anti-CD20 therapy for non-active secondary progressive multiple sclerosis, targeting neuroinflammation through a novel nasal spray delivery method. According to Brigham and Women’s Hospital, the study evaluates whether modulating the immune system locally can alter disease progression where standard therapies fall short.
Clinical Trial Design and Drug Mechanisms
The trial investigates the nasal administration of foralumab, a fully human anti-CD3 monoclonal antibody, paired alongside an anti-CD20 therapy. Anti-CD20 therapies constitute a class of treatments that include FDA-approved relapsing-remitting multiple sclerosis medications such as ublituximab-xiiy, marketed as Briumvi. According to Harvard Medical School researchers, foralumab works by dampening T cell activation in the nasal mucosa, which subsequently reduces neuroinflammation in the central nervous system without causing systemic immunosuppression.
Addressing Non-Active Secondary Progressive MS
Secondary progressive multiple sclerosis often follows an initial relapsing-remitting course, eventually shifting into a phase characterized by steady physical and cognitive decline. Non-active secondary progressive MS presents a distinct clinical challenge because patients experience disability progression independent of traditional relapse activity or new contrast-enhancing lesions on MRI scans. According to clinical investigators at Brigham and Women’s Hospital, current approved treatments struggle to halt neurodegeneration once this non-active phase establishes itself, making combination immunomodulatory approaches an urgent priority.
Safety and Delivery Innovation
Traditional monoclonal antibody treatments require intravenous or subcutaneous infusions, which often carry high systemic side effect profiles and substantial clinical overhead. By contrast, nasal delivery allows patients to administer foralumab themselves at home. According to preliminary safety data published by researchers at Brigham and Women’s Hospital from prior phase trials in COVID-19 and mild-to-moderate multiple sclerosis, intranasal foralumab demonstrated a favorable safety profile with minimal systemic adverse events.
Frequently Asked Questions
What is foralumab?
Foralumab is a fully human anti-CD3 monoclonal antibody designed to downregulate inflammation by targeting T cells. Unlike most monoclonal antibodies given via infusion, it is formulated as a nasal spray.
How does anti-CD20 therapy fit into the trial?
Anti-CD20 therapies deplete B cells, which play a major role in driving the autoimmune activity of multiple sclerosis. Combining an anti-CD20 drug with nasal foralumab targets both B cell and T cell pathways simultaneously.
Who is eligible for this trial?
The trial focuses specifically on patients diagnosed with non-active secondary progressive multiple sclerosis who meet specific clinical and demographic inclusion criteria set by Brigham and Women’s Hospital.
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