Phase 2 Subpopulation Data of Vidofludimus Calcium in Progressive Multiple Sclerosis: Robert J. Fox, MD

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"Vidofludimus calcium, although it did not decrease the rate of brain atrophy progression over the 2 years, [it] showed some suggestive trends about slowing disability progression and doing it regardless of patient subset—primary progressive [MS] versus nonrelapsing secondary progressive [MS]."

Vidofludimus calcium (VidoCa; Immunic), a nuclear receptor related 1 (Nurr1) activator, is an oral, once-daily investigational agent currently being assessed in the phase 2 CALLIPER study (NCT05054140) for primary progressive multiple sclerosis (PPMS). CALLIPER is a randomized, double-blind, placebo-controlled trial that enrolled 152 adult patients with PPMS who received either 45 mg VidoCa or matching placebo. The study’s primary end points were annualized rate of percentage of brain volume change and 24-week confirmed disability worsening (CDW).¹

Subpopulation analyses from the CALLIPER study presented as a late breaker at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, held September 24-26, in Barcelona, Spain, revealed that treatment with VidoCa may have a modest clinical effect in slowing disability progression in patients with PPMS, including those without active inflammation at baseline.² Presented by lead author Robert J. Fox, MD, staff neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic, the findings demonstrated consistent CDW hazard ratios below 1.0 for time across multiple PPMS subgroups, supporting further evaluation in a larger phase 3 trial.

At the Congress, Fox spoke with NeurologyLive^® to review the presented results from CALLIPER, noting that the study did not meet its primary end point. Despite this, Fox explained that exploratory analyses showed consistent, though not statistically significant, trends toward reduced disability progression across multiple measures, including EDSS-based outcomes. He noted that these trends were observed across key subgroups, regardless of disease subtype or baseline gadolinium-enhancing lesions. Throughout the discussion, Fox also emphasized the favorable safety profile of VidoCa, highlighting the absence of safety signals commonly associated with teriflunomide (Aubagio; Sanofi) and supporting further phase 3 evaluation in progressive MS.

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REFERENCES
1. Fox RJ, Wolf C, Nasta M, et al. Efficacy and Safety of Vidofludimus Calcium, a novel Nurr1 activator and DHODH inhibitor, in Primary Progressive Multiple Sclerosis (PPMS): Subpopulation Data from the Phase 2 CALLIPER Trial. Presented at: 2025 ECTRIMS Congress; September 24-26; Barcelona, Spain. ABSTRACT P417.
2. Immunic Presented Key Vidofludimus Calcium Data at the 41st Congress of ECTRIMS, Highlighting Its Potential in Multiple Sclerosis. News release. Immunic. September 25, 2025. Accessed January 7, 2025. https://imux.com/immunic-presented-key-vidofludimus-calcium-data-at-the-41st-congress-of-ectrims-highlighting-its-potential-in-multiple-sclerosis/