The trial enrolled 238 adults from 104 international sites, comprising 190 patients in the AChR+ group and 48 patients in the MuSK+ group. Credit: shutterstock / CGN089.
Amgen’s Uplizna (inebilizumab-cdon) has shown sustained efficacy in a group of generalised myasthenia gravis (gMG) patients after 52 weeks in a Phase III trial.
Results from the company’s double-blind, placebo-controlled Mint study (NCT04524273) showed 72.3% of acetylcholine receptor autoantibody-positive (AChR+) gMG patients dosed with Uplizna saw a more than three-point improvement on the Myasthenia Gravis Activities of Daily Living (MG-DAL) scale. This is compared to just 45.2% in the placebo group.
The MG-DAL uses points to quantify the impact of muscle fatigue in various areas of the body.
There was also a change in the Quantitative Myasthenia Gravis (QMG) score, with 69.2% of AChR+ patients in the Uplinza group improving by three or more points compared to 41.8% in the placebo group.
Previously the company announced 26-week data that tracked a sub-population living with the muscle-specific kinase autoantibody-positive (MuSK+) variant of the disease. In those results, patients saw a median improvement of 4.2 points. Patients in the MuSK+ arm were only evaluated for 26 weeks.
The trial enrolled 238 adults from 104 international sites, comprising 190 patients in the AChR+ group and 48 patients in the MuSK+ group. The trial has already hit its primary endpoint at the 26-week mark, measuring a change from baseline in MG-ADL score at week 26 in the combined population.
Now, the company plans to unveil full results during the American Academy of Neurology (AAN) Annual Meeting on 8 April.
Amgen’s research and development executive vice president Jay Bradner 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 — while underscoring our commitment to developing transformative therapies for people facing complex autoimmune diseases.”
Uplizna is currently approved in the US for use in Neuromyelitis Optica, also known as Devic’s Syndrome, another autoimmune disorder in which the body’s immune system attacks the optic nerves and spinal cord. At the same time, it is under priority review by the US Food and Drug Administration (FDA) for the treatment of Immunoglobulin G4-related disease (IgG4-RD).
GlobalData’s Pharmaceutical Intelligence Centre found that in 2024 Uplizna, an anti-CD-19 antibody therapy, brought in total sales of $379m, with that number predicted to rise to $1.1bn by the end of 2028, continuing on to $1.4bn by the end of 2030.
Across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) the interest in gMG treatments is set to rise from $2.3bn in 2023 to $5.2bn by 2033 according to a GlobalData analyst.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of gMG, Cartesian Therapeutics has announced updated efficacy and safety data from the Phase IIb trial of its mRNA cell therapy candidate.
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