James F. Howard, MD, Distinguished Professor of Neuromuscular Disease, Professor of Neurology, Medicine and Allied Health in the UNC School of Medicine, was lead investigator in the Phase 3 clinical trial of zilucoplan.
UCB, a global biopharmaceutical company, announced results from two phase 3 studies evaluating its investigational treatments, zilucoplan, a self-administered, subcutaneous peptide inhibitor of complement component 5 and rozanolixizumab, a monoclonal antibody targeting the neonatal Fc receptor in adults with generalized myasthenia gravis.
These results will be presented as posters at the 14th Myasthenia Gravis Foundation of America International Conference on Myasthenia and Related Disorders, taking place from May 10-12, 2022.
Phase 3 RAISE results
Data from the Phase 3 RAISE trial (NCT04115293) (poster 26)1 demonstrated treatment with zilucoplan (0.3 mg/kg daily) resulted in clinically meaningful and statistically significant improvements in key gMG-specific outcomes compared with placebo in patients with acetylcholine receptor autoantibody positive (AChR+) gMG.
“The results from the RAISE study are an exciting development in the gMG treatment paradigm and reinforce the critical role that complement inhibition could play for physicians treating patients with this debilitating illness. By targeting the underlying mechanisms of gMG at the neuromuscular junction, complement inhibitors like zilucoplan have the potential to provide rapid, consistent disease control earlier in the disease course. These findings are an encouraging sign that we may be able to meet patients’ needs effectively, with treatments that are minimally invasive and well tolerated,” said James F. Howard, MD, Distinguished Professor of Neuromuscular Disease, Professor of Neurology, Medicine and Allied Health, The University of North Carolina at Chapel Hill School of Medicine and lead investigator in the RAISE trial.