**Amgen has shared new data from a late-stage trial of its B cell-depleting therapy Uplizna (inebilizumab-cdon) in adults with the rare autoimmune disorder generalised myasthenia gravis (gMG).**
The phase 3 MINT trial evaluated the efficacy and safety of the drug in both muscle-specific kinase autoantibody (MuSK)-positive and acetylcholine receptor autoantibody (AChR)-positive gMG patients, who were followed for 26 and 52 weeks, respectively.
Amgen previously reported that the trial met its primary endpoint, with Uplizna demonstrating a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores compared with placebo at week 26 in the combined study population.
New results from the study have shown durable and sustained efficacy of Uplizna in patients with AChR-positive gMG with two doses a year, following an initial loading dose. Among these patients 72.3% of those receiving Uplizna had at least a three point improvement in the MG-ADL score, compared to 45.2% in placebo.
Up to 100,000 people in the US are affected by myasthenia gravis, with gMG accounting for approximately 85% of all cases. The disease impairs neuromuscular communication and can cause muscle weakness, trouble breathing, difficulty swallowing and impaired speech and vision.
Uplizna is a humanised monoclonal antibody that works by reducing the number of B cells, which are central to the pathogenesis of gMG. The drug already holds approvals to treat certain adults with neuromyelitis optica spectrum disorder, a rare autoimmune disease that attacks the optic nerve, spinal cord, brain and brainstem, and is under priority review in the US for immunoglobulin G4-related disease.
Regulatory filing activities for Uplizna in gMG are underway, with submissions expected to be complete in the first half of 2025, according to Amgen.
Jay Bradner, executive vice president of research and development at Amgen, said: “The 52-week MINT trial results highlight the potential for a new standard of care in gMG, offering durable symptom relief with a simplified treatment regimen.
“These findings reinforce Uplizna’s ability to provide sustained symptom relief with just two doses per year – an important advancement for patients living with gMG…”