Promising Effects of Vidofludimus Calcium by Age and Disability in Progressive MS: Robert J. Fox, MD; Andreas Muehler, MD, MBA

WATCH TIME: 4 minutes

"We are seeing consistent trends of reduction in serum neurofilament light with vidofludimus calcium, indicating potential neuroprotective benefits in both younger and older patients with [multiple sclerosis]."

Vidofludimus calcium (Immunic Therapeutics), a highly selective 2nd generation dihydroorotate dehydrogenase inhibitor, is being investigated for its neuroprotective effects in the phase 2 CALLIPER trial (NCT05054140) of patients with progressive multiple sclerosis (MS). Recent data from an interim analysis of CALLIPER demonstrated that treatment with the therapeutic consistently reduced neurofilament light (NfL) levels compared with placebo across different patient subgroups based on age and disability scores, supporting the potential efficacy of the treatment in slowing disease progression in progressive MS.¹

Presented at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, September 18-20, in Copenhagen, Denmark, by lead author Robert J. Fox, MD, and colleagues, the study randomized 467 patients with primary progressive MS (35.2%), non-active secondary progressive MS (59.5%) and active secondary progressive MS (7.9%) to vidofludimus calcium or placebo over 120 weeks. Investigators performed a preplanned interim analysis assessing serum NfL (sNFL) after half of the participants completed 24 weeks of the treatment and had biomarker data available at baseline and week 24.

Among 203 patients in this interim analysis, researchers reported that serum NfL levels reduced by 22.4% (P = 0.01) after 24 weeks of vidofludimus calcium treatment, with consistent treatment effect across each progressive MS subtype. Notably, the vidofludimus calcium group displayed a 10% decrease compared with a 20% increase sNFL for placebo among those with Expanded Disability Status Scale (EDSS) no more than 5.5.

Investigators observed a 2% decrease in sNFL for vidofludimus calcium treatment in comparison with a 12% increase for placebo among those with EDSS of more than 5.5. Similarly, in patients aged no more than 45 years, researchers observed a sNFL reduction of 11.6% for vidofludimus calcium group compared with a 15% increase for the placebo group as well as for those aged more than 55 years, it was a 10% decrease sNFL compared with a 13% increase, respectively.

During the 2024 ECTRIMS Congress, Fox, a staff neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic, and senior author Andreas Muehler, MD, MBA, chief medical officer at Immunic, sat down with NeurologyLive^® to discuss the dual mechanisms of action for vidofludimus calcium, and how they contribute to its therapeutic potential in MS. The duo also spoke about the significance of the 22% reduction in sNFL hold for the progression of MS in treated patients. Moreover, Fox and Muehler talked about how the ongoing Caliper trial assesses the effectiveness of vidofludimus calcium in reducing whole brain atrophy in progressive MS.

Click here for more coverage of ECTRIMS 2024.

REFERENCES
1. Fox RJ, Wolf C, Ondruš M, et al. Serum Neurofilament Changes in Progressive MS: Exploring the Impact of Vidofludimus Calcium by Age and Disability in the CALLIPER Study Interim Analysis. Presented at: 2024 ECTRIMS; September 18-20; Copenhagen, Denmark. Abstract 686.