THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN) has revealed positive results from its Phase 3 MINT trial for UPLIZNA (inebilizumab-cdon), a treatment for adults with generalized myasthenia gravis (gMG). The findings, presented at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, indicated significant improvements in daily living activities for patients with this autoimmune disorder.
The trial met its primary endpoint, showing a statistically significant change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 for patients treated with UPLIZNA compared to those given a placebo. The study included both acetylcholine receptor autoantibody-positive (AChR+) and muscle-specific kinase autoantibody-positive (MuSK+) patients. Participants received the treatment on Day 1 and Day 15 and were observed through Week 26.
Significantly, the trial is the first Phase 3 placebo-controlled study for a biologic in gMG that included a protocol-specified tapering of corticosteroids, which began at Week 4. By Week 24, patients were tapered down to prednisone 5 mg per day. No new safety signals were identified during the trial.
Secondary endpoints also showed UPLIZNA's efficacy, with meaningful changes from baseline in the Quantitative Myasthenia Gravis (QMG) score for both AChR+ and MuSK+ populations at Week 26 compared to placebo. However, in the MuSK+ group, changes in QMG score were not statistically significant.
Dr. Jay Bradner, executive vice president at Amgen, highlighted UPLIZNA's potential as a bi-annual infusion and its mechanism targeting CD19+ B cells, key drivers of the disease. The MINT trial's results support UPLIZNA's efficacy in severe autoimmune diseases and Amgen's leadership in B-cell targeting therapeutics.
The trial's global principal investigator, Dr. Richard J. Nowak, emphasized the clinically meaningful benefits of UPLIZNA, particularly in light of the steroid tapering aspect, which could reduce the overall burden of disease management for patients.
With the largest enrollment of MuSK+ patients in a placebo-controlled gMG biologic trial, further data will characterize UPLIZNA's efficacy and safety over 12 months in AChR+ patients with gMG.
UPLIZNA is currently approved for neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive in multiple regions, including the United States and European Union. Following these trial results, Amgen plans to seek approval for UPLIZNA in the U.S. and other key markets for the treatment of gMG.
This article is based on a press release statement from Amgen.
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