Amgen announced today the positive top-line results from the Phase 3 MINT trial, evaluating the efficacy and safety of UPLIZNA ® (inebilizumab-cdon) for the treatment of adults with generalized myasthenia gravis (gMG), a rare autoimmune disorder. The trial, presented at the Myasthenia Gravis Foundation of America (MGFA) Scientific Session during the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, met its primary endpoint. The results showed a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared with placebo.
Dr. Jay Bradner, Executive Vice President, Research and Development, and Chief Scientific Officer at Amgen, expressed that patients with gMG deserve an effective treatment option providing long-term symptom relief. UPLIZNA targets CD19+ pre-B cells, mature B-cells, and some plasmablasts, all of which drive the disease. The results from the MINT trial reinforce the evidence for UPLIZNA in severe autoimmune diseases and demonstrate Amgen’s leadership in B-cell targeting therapeutics.
Key secondary endpoints in the trial also showed favorable results for UPLIZNA compared to placebo. The safety profile of UPLIZNA during the trial was consistent with known safety data. The most common treatment-emergent adverse events were observed, including COVID-19, nasopharyngitis, urinary tract infection, infusion-related reactions, headache, and cough.
The MINT trial is the largest placebo-controlled gMG clinical trial for a biologic therapy, enrolling 238 adults with gMG. Further data from the trial will continue to characterize the efficacy and safety of UPLIZNA over 12 months in AChR+ patients with gMG. UPLIZNA is currently approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Based on the primary results of the MINT trial, Amgen plans to seek approval in the U.S. and other key markets. The company aims to provide innovative medicines to help patients combat tough diseases and continues to push the boundaries of medical innovation.
