First Participant Enrolled in Phase 3 Study of Vidofludimus Calcium for Relapsing Multiple Sclerosis   

The first participant has enrolled in the phase 3 ENSURE-1 clinical trial (NCT05134441) of vidofludimus calcium (IMU-838; Immunic Therapeutics, New York, NY) for potential treatment of relapsing multiple sclerosis (MS). 

The ENSURE trial is 1 of 2 multicenter, randomized, double-blind phase 3 trials of vidofludimus calcium vs placebo in people with relapsing MS, each of which is expected to enroll approximately 1,050 adults. There are more than 100 study sites in more than 15 countries. Participants will receive either 30 mg/day of vidofludimus calcium or placebo. Efficacy is being measured as time to first relapse over a 72-week period. Key secondary endpoints include time to confirmed disability progression, time to sustained clinically relevant changes in cognition, and MRI biomarkers of changes in whole brain, grey matter, white matter, and T2-lesion volume. 

“The ENSURE program, along with the supportive phase 2 CALLIPER trial (NCT05054140) in progressive MS, designed to corroborate the neuroprotective potential of vidofludimus calcium and back its differentiated profile, gives us a strong foundation from which we hope to ultimately position the drug as a preferred oral therapeutic option that allows MS patients to continue their normal social lives without being reminded that they are on a chronic treatment,” said Andreas Muehler, MD, chief medical officer, Immunic.  
Vidofludimus calcium is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking dihydroorotate dehydrogenase (DHODH). The therapy acts on activated T-cells and B-cells while leaving other immune cells largely unaffected, to maintain a functional immune system.