Regeneron's Phase 3 NIMBLE Study Of Cemdisiran In Generalized Myasthenia Gravis Meets Primary Goal

(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) Tuesday said that its Phase 3 NIMBLE study evaluating the company's drug candidate cemdisiran in adults with generalized myasthenia gravis, an autoimmune disease that causes weakness in voluntary muscles, met its primary goal.

In the study, patients were randomized to receive cemdisiran 600 mg every three months, cemdi-poze (cemdisiran 200 mg and pozelimab 200 mg) every month, or placebo every month. Cemdisiran monotherapy met the primary endpoint showing a 2.3-point placebo-adjusted improvement in Myasthenia Gravis Activities of Daily Living(MG-ADL) total score. Additionally, there were no meningococcal infections in any patient or treatment discontinuations due to adverse events through week 24 in the cemdisiran arm.