Dosage Finding for IMU-838 in Relapsing MS: Robert Fox, MD

“There is a third cohort that is being evaluated with 10 mg. That will help us identify what is the minimally effective dose, and based on the results of that additional cohort, we will then be able to decide what dose to take into a phase 3, clinically powered trial.”

Oral vidofludimus calcium (IMU-838) reduced combined unique active (CUA) magnetic resonance imaging (MRI) lesions in patients with relapsing multiple sclerosis (RMS) according to 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.

Fox and colleagues studied 2 dosages, 30 mg (n = 71) and 45 mg (n = 69), and compared them 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 efficacy of the 30-mg and 45-mg doses and the third cohort in which a 10-mg dose is being investigated. He discussed how finding the minimally effective dose is crucial to being able to start a phase 3 clinical trial.

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REFERENCE

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