Advantages of IMU-838 Over Teriflunomide for MS: Robert Fox, MD


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.

For more coverage of AAN 2021, click here.

Fox RJ, Wiendl H, De Stefano N, Sellner J, Muehler A. Efficacy and safety of the selective oral DHODH modulator vidofludimus calcium (IMU-838) in relapsing multiple sclerosis (EMPhASIS): a randomized, placebo-controlled phase 2 trial. Presented at 2021 American Academy of Neurology Annual Meeting; April 17-22. Abstract P15 085
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