The Vice-Chair for Research at the Cleveland Clinic Neurological Institute discussed topline results from the EMPhASIS trial of IMU-838.
“IMU-838 is a next generation small molecule dihydroorotate dehydrogenase inhibitor. So, it is similar to teriflunomide, which is a currently approved therapy for MS, but it lacks the off-target effects on kinases. So, we think it may have a better safety and tolerability profile than the currently available teriflunomide.”
Topline results from the phase 2 double-blind, placebo-controlled, randomized, parallel-group EMPhASIS trial (NCT03846219) presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22, by Robert J. Fox, MD, neurologist, Mellen Center for Multiple Sclerosis, and Vice-Chair for Research, Neurological Institute, Cleveland Clinic suggest that oral vidofludimus calcium (IMU-838) reduced combined unique active (CUA) magnetic resonance imaging (MRI) lesions in patients with relapsing multiple sclerosis (RMS).
Fox and colleagues studied 2 dosages, 30 mg (n = 71) and 45 mg (n = 69) compared to placebo (n = 69). Five patients (7.2%) discontinued in the placebo group due to liver enzyme elevations (n = 2), cervix carcinoma (n = 1), and hematuria (n = 1). Two (2.8%) discontinued in the 30-mg group for no reported reasons and 4 (5.8%) discontinued in the 45-mg group for liver enzyme elevations (n = 2) and rash (n = 1).
NeurologyLive spoke with Fox to learn more about the advantages of IMU-838 compared to teriflunomide (Aubagio; Sanofi) in treating this patient population. He additionally discussed the relatively low prevalence of adverse events seen in the EMPhASIS trial.
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