First Participant Enrolls in Clinical Trial of Vidofludimus Calcium for Relapsing Multiple Sclerosis

 The twin phase 3 clinical trials ENSURE-1 clinical trial (NCT05134441) of vidofludimus calcium (IMU-838; Immunic Therapeutics, New York, NY) enrolled the first participant for potential treatment of relapsing multiple sclerosis (RMS). Outcomes measure include relapse rate, brain volume changes, brain lesions, cognition, disability progression. The 2 identical clinical trials are intended to provide more reliable data. 

Participants (n=1,050 adults with active RMS) will receive either 30 mg daily doses of vidofludimus calcium or placebo at more than 100 sites in more than 15 countries. The clinical trial is aimed to evaluate time to first relapse in the participants when taking treatment for up to 72 weeks.

In the EMPhASIS trial (NCT03846219), which provides supporting data for vidofludimus calcium, there was a very low discontinuation rate for participants treated with vidofludimus calcium. There was a lack of adverse events such as hepatotoxicity signals and a decrease of serum neurofilament light chain. Vidofludimus calcium demonstrates potential with placebo like safety profile and robust anti-inflammatory and neuroprotective properties. 

The phase 3 program’s trial design has been approved by many ethics committees and regulators, validating Immunic’s approach. “The ENSURE program, along with the supportive phase 2 CALLIPER trial (NCT05054140) in progressive multiple sclerosis, 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 of Immunic.