A second-generation anti-CD40L monoclonal antibody suppresses multiple sclerosis (MS) disease activity on MRI to an uncommonly high degree, new trial data suggested.
NASHVILLE, Tennessee — A second-generation anti-CD40L monoclonal antibody suppresses multiple sclerosis disease activity on MRI to an uncommonly high degree, new trial data suggested.
In the double-blind randomized phase 2 trial, 125 patients with MS of all other MS therapy were randomized in a 4:4:4:1 ratio to 1200-mg frexalimab administered intravenously every 4 weeks after a loading dose, to 300-mg frexalimab administered subcutaneously every 2 weeks after a loading dose, or to one of the two matching placebo arms.
By 24 weeks, the number of new Gd+ T1 lesions had fallen to 0.3 in placebo patients switched to the higher dose and 1.0 in those switched to the lower dose.The proportions of patients free of new Gd+ T1 lesions at 48 weeks were 96% in the group started and maintained on the highest dose of frexalimab, 87% in those started and maintained on the lower dose, 90% in those started on placebo and switched to the highest dose of frexalimab, and 92% of placebo patients switched to the lower dose.
A first-generation monoclonal antibody directed at elevated levels of CD40L, which is implicated in the inflammation that drives MS, showed promise but was abandoned after it was associated with an increased risk for thromboembolic events in a phase 1 trial, she said.As with the first-generation agent, frexalimab had little or no impact on lymphocyte count or immunoglobulin G and immunoglobulin M levels.
He noted that the phase 2 open-label follow-up continues to support the promise of frexalimab. But Cohen cautioned that this does not obviate the need for phase 3 data.
Multiple Sclerosis MS MS - Multiple Sclerosis Lymphocytes Monoclonal Antibody Cetuximab Rituximab Iga Immunoglobulin A Biologic Therapy Biologics Oklahoma Brain Central Nervous System Cns Match Match Day Match Application Medical Students Match Common Cold Acute Nasopharyngitis Platelet Count PLT - Platelet Count Thrombocyte Count Platelets Thrombocytes
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