Amgen reports new data from Phase 3 registrational MINT trial of Uplinza

Amgen (AMGN) announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of Uplinza in adults living with generalized myasthenia gravis. The results demonstrated durable and sustained efficacy of Uplinza in patients with acetylcholine receptor autoantibody-positive gMG with two doses a year, following an initial loading dose. Findings will be presented as a late-breaking oral presentation during the American Academy of Neurology Annual Meeting on April 8, in San Diego. The Phase 3 MINT trial, which was a randomized-control trial, evaluated Uplinza in muscle-specific kinase autoantibody-positive and AChR+ gMG patients, with the MuSK+ group followed for 26 weeks and the AChR+ group followed for 52 weeks. The trial demonstrated continued improvement in efficacy of Uplinza compared to placebo as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living score in the AChR+ subpopulation through week 52. Among the AChR+ patients in the Uplinza group, 72.3% had a greater than or equal to3 point improvement in the MG-ADL score, compared to 45.2% in placebo.