Positive topline results were announced from a phase 3 study evaluating the efficacy and safety of rozanolixizumab in adults with generalized myasthenia gravis.
Rozanolixizumab is a humanized monoclonal antibody that specifically binds to human neonatal Fc receptor (FcRn) with high affinity. The investigational treatment is designed to block the interaction of FcRn and immunoglobulin G, accelerating the catabolism of antibodies and inducing the removal of pathogenic IgG autoantibodies.
The multicenter, randomized, double-blind, placebo-controlled MycarinG study (ClinicalTrials.gov Identifier: NCT03971422) included approximately 200 adults with generalized myasthenia gravis. Patients were randomly assigned to receive either rozanolixizumab or placebo subcutaneously.
Results demonstrated that treatment with rozanolixizumab met the primary endpoint achieving statistically significant and clinically meaningful change from baseline to day 43 in the Myasthenia Gravis-Activities of Daily Living Profile score. Rozanolixizumab also met all secondary endpoints which included response rates, changes in the Myasthenia Gravis composite score, the Quantitative MG score, and patient-reported outcomes.
As for safety, rozanolixizumab was well tolerated with no new signals identified. Final study data will be presented at a forthcoming medical meeting in 2022.
“For the many thousands of people living with myasthenia gravis around the world, current treatment options can be very limited,” said Samantha Masterson, President and CEO of the Myasthenia Gravis Foundation of America (MGFA). “Given that this disease causes a wide range of symptoms, some of which can require urgent intervention or hospitalization, there is a critical need for new treatment options that could address the unmet needs of patients living with myasthenia gravis.”
UCB announces positive phase 3 results for rozanolixizumab in generalized myasthenia gravis. News release. UCB. Accessed December 10, 2021. https://prnmedia.prnewswire.com/news-releases/ucb-announces-positive-phase-3-results-for-rozanolixizumab-in-generalized-myasthenia-gravis-301441959.html.