Immunic Advances Vidofludimus Calcium MS Data at MSToronto2026

NEW YORK, October 7, 2026

Immunic Highlights Long-Term Disability Data

One of the featured presentations will provide new findings from the Phase 2 CALLIPER trial and its open-label extension, focusing on disability outcomes in patients with progressive multiple sclerosis. The analysis compares participants who continued vidofludimus calcium treatment with those who switched from placebo when entering the open-label extension. A high proportion of participants transitioned into the extension period, while treatment discontinuation remained low. The open-label extension analysis showed that trends toward a lower risk of 24-week confirmed disability worsening were maintained through extension Week 48. Confirmed disability improvement was also observed more frequently, providing additional information about the potential effects of continuous treatment on disability outcomes in progressive MS. These findings are particularly relevant because progressive forms of MS can involve gradual accumulation of disability and remain an area of significant unmet medical need. The CALLIPER presentation will be delivered as a paper poster during Poster Session 1 on October 21.

Vidofludimus Calcium Shows Nurr1 Neuroprotective Activity

Immunic will also present new preclinical evidence supporting the neuroprotective mechanism of vidofludimus calcium. The candidate is described as a nuclear receptor-related 1 (Nurr1) activator, and new laboratory findings indicate that Nurr1 is important for the compound’s direct neuronal survival activity. In human neuronal cells exposed to apoptotic stress, vidofludimus calcium increased neuronal survival, while this effect was abolished following Nurr1 knockout, suggesting that Nurr1 is required for the observed pro-survival activity in vitro. Additional findings from murine models of multiple sclerosis showed that vidofludimus calcium attenuated microglia-driven neuronal loss, reduced disease severity and increased expression of Nurr1-regulated genes. Treatment also reduced plasma neurofilament light chain, a biomarker associated with neuronal injury, in experimental autoimmune encephalomyelitis models. Together, these findings provide mechanistic evidence for further investigation of the candidate’s potential neuroprotective properties in MS.

Immunic Explores EBV, Cognition and Disability Measures

Another accepted presentation will examine the relationship between Epstein-Barr virus (EBV)-related immune activity and cognitive performance in progressive MS. In a post-hoc analysis of CALLIPER, vidofludimus calcium significantly reduced EBV-specific T-cell receptor signatures compared with placebo, while influenza A-specific signatures remained unchanged. Reductions in EBV-specific signatures were associated with improved performance on the Symbol Digit Modalities Test (SDMT) across treatment groups, with the association primarily driven by participants with primary progressive MS. Immunic describes these findings as exploratory and says they support further investigation of the relationship between EBV-related immune activity and cognition. The fourth presentation evaluates a proposed bidirectional disability endpoint designed to capture both disability worsening and improvement rather than focusing solely on deterioration.

The analysis of CALLIPER data produced statistically significant results using confirmed disability change, with similar findings observed using the Generalized Pairwise Comparisons methodology. Immunic said these findings support additional evaluation of endpoints that may provide a more comprehensive assessment of treatment effects in progressive MS. Vidofludimus calcium is currently being evaluated in Phase 3 clinical trials for relapsing multiple sclerosis, while Immunic expects to initiate another Phase 3 trial in progressive MS later in 2026. The company says top-line Phase 3 data in relapsing MS are expected by the end of 2026. However, vidofludimus calcium remains investigational and has not been approved by the FDA, EMA or any other regulatory authority, and its safety and efficacy have not been established.

Source: Immunic press release