Amgen (NASDAQ: AMGN) has released positive top-line results from the Phase 3 MINT trial, which evaluated the efficacy and safety of UPLIZNA ® (inebilizumab-cdon) for the treatment of adults with generalized myasthenia gravis (gMG), an uncommon autoimmune disorder. The trial, a randomized, double-blind, placebo-controlled study, met its primary endpoint by showing a significant change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared to placebo. These results will be presented at the Myasthenia Gravis Foundation of America (MGFA) Scientific Session during the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting.
Dr. Jay Bradner, the Executive Vice President of Research and Development and Chief Scientific Officer at Amgen, highlighted the importance of providing effective treatment options for patients with generalized myasthenia gravis. UPLIZNA targets CD19+ pre-B cells, mature B-cells, and some plasmablasts that drive the disease. The trial results reinforce the growing evidence for UPLIZNA in treating severe autoimmune diseases and underscore Amgen’s expertise in B-cell targeting therapeutics.
Key secondary endpoints in the trial showed significant and clinically meaningful changes in the Quantitative Myasthenia Gravis (QMG) score and MG-ADL score for different patient populations. The safety profile of UPLIZNA during the trial was consistent with known information. Notably, MINT is the largest placebo-controlled gMG clinical trial for a biologic therapy, including a substantial number of MuSK+ patients, and promising data on UPLIZNA’s long-term efficacy is expected.
Amgen plans to seek approval for UPLIZNA in the U.S. and other key markets based on the favorable results from the MINT trial. UPLIZNA is currently approved for treating neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Additionally, UPLIZNA recently received Breakthrough Therapy Designation for IgG4-Related Diseases based on Phase 3 results announced earlier this year.
The MINT trial, a Phase 3 study, evaluated the efficacy and safety of UPLIZNA in adults with gMG. The trial included patients with acetylcholine receptor autoantibody-positive (AChR+) and muscle-specific kinase autoantibody-positive (MuSK+) gMG. Results from the trial demonstrated the potential of UPLIZNA in providing clinical benefits to patients with gMG.
Generalized myasthenia gravis is a rare, chronic autoimmune disorder that affects neuromuscular communication, leading to muscle weakness and other debilitating symptoms. The prevalence and incidence of gMG are increasing globally, highlighting the need for effective treatment options like UPLIZNA.
Amgen is a leading biotechnology company focused on developing innovative medicines to combat challenging diseases. Their commitment to innovation and cutting-edge research has positioned them as a key player in the biopharmaceutical industry. For more information about Amgen and their groundbreaking work, please visit Amgen.com.
