– New Phase 2 CALLIPER Open-Label Extension Data Support Durability of Disability Outcomes Observed During the Double-Blind Period With Continued Vidofludimus Calcium Treatment; Safety and Tolerability Profile Appeared Consistent With That Observed in the Double-Blind Period –
– New Preclinical Data Suggest Nurr1-Dependent Neuronal Survival and Neuroprotective Effects Beyond DHODH Inhibition –
– Exploratory and Post-hoc CALLIPER Analyses Show Significant Reductions in EBV-Specific T-Cell Receptor Signatures; Observed Reductions Associated With Increased Symbol Digit Modalities Test (SDMT) Scores –
– Post-hoc Analysis of CALLIPER Using a Proposed Novel Disability Measure Suggests Overall Benefit of Vidofludimus Calcium in Progressive Multiple Sclerosis Patients –
NEW YORK, Oct. 21, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced that new clinical, biomarker, and preclinical data for its lead investigational asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), are being presented across four poster presentations at MSToronto2026 – the 10th Joint ACTRIMS-ECTRIMS Meeting, taking place October 21-23, 2026, in Toronto. All posters are available on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, the team is available throughout the event at booth #516.
"The data presented at MSToronto2026 provide complementary clinical and mechanistic evidence supporting the differentiated profile of vidofludimus calcium across the multiple sclerosis (MS) spectrum," said Erik Lundgren, Chief Executive Officer of Immunic. "Importantly, the new CALLIPER open-label extension (OLE) analyses provide favorable long-term follow-up of the disability signals observed during the double-blind treatment period, while the Nurr1, Epstein-Barr virus (EBV), and disability endpoint analyses provide additional insight into the biology of disease progression and how treatment effects may be more comprehensively measured. Together, these findings further support the clinical and scientific rationale for our planned Phase 3 program in progressive MS, which we expect to initiate later this year, while we also approach the top-line results from our fully enrolled Phase 3 ENSURE trials in relapsing MS, expected by year-end 2026."
New Phase 2 CALLIPER Open-Label Extension Data Support Durability of Disability Outcomes
Poster Title: Evaluation of Disability Outcomes from the Open-Label Extension of CALLIPER: A Phase 2 Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis
- Lead Author: Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio and Coordinating Investigator of the CALLIPER trial
- Presentation: Paper Poster, Poster Number P0387
- Date and Time: Poster Session 1, Wednesday, October 21, 2026, 4:30 - 6:30 pm ET
New analyses of the Phase 2 CALLIPER trial showed that the favorable trends on disability outcomes observed during the double-blind main treatment period were maintained during the OLE phase among participants who continued vidofludimus calcium treatment. Only 6.5% of patients discontinued through the January 27, 2026 data cutoff, with a safety and tolerability profile that appeared consistent with that observed in the double-blind period.
Preclinical Models Suggest Nurr1-Dependent Neuronal Survival and Neuroprotective Effects
Poster Title: Vidofludimus Calcium Requires Nurr1 to Promote Neuronal Survival In Vitro and Is Associated with Neuroprotective Effects in Murine Models of Multiple Sclerosis
- Lead Author: Mehrnoosh Jafari, Senior Manager Translational Pharmacology at Immunic
- Presentation: Paper Poster, Poster Number P1273
- Date and Time: Poster Session 2, Thursday, October 22, 2026, 4:30-6:30 pm ET
New preclinical findings across multiple models suggest that vidofludimus calcium promotes neuronal survival under apoptotic stress conditions, an effect requiring Nurr1, and in addition reduces microglia-driven neuronal loss, supporting direct and indirect neuroprotective mechanisms. Under in vitro apoptotic conditions, vidofludimus calcium promoted neuronal survival, an effect not observed with teriflunomide, suggesting that the observed pro-survival effect involves mechanisms beyond DHODH inhibition.
Vidofludimus calcium also reduced disease severity and plasma neurofilament light (NfL) chain levels in murine experimental autoimmune encephalomyelitis (EAE) models, and increased brain-derived neurotrophic factor (BDNF) levels and expression of Nurr1-regulated target genes, providing additional evidence consistent with activation of Nurr1-pathways.
Taken together, these findings provide further preclinical evidence of the profile of vidofludimus calcium on pathways associated with neuroprotective effects.
Exploratory and Post-hoc CALLIPER Analyses Link Reduced EBV-Specific T-Cell Signatures with Improved Cognitive Performance as Measured by the Symbol Digit Modalities Test
Poster Title: Anti-EBV T-cell Receptor Repertoire Reduction Is Linked to Enhanced Cognitive Performance in Progressive Multiple Sclerosis: Evidence from the Phase 2 CALLIPER Trial with Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor
- Lead Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development at Immunic
- Presentation: ePoster, Number EP2473
- Date and Time: ePoster screens within the congress center and on the congress platform for the duration of the congress
An exploratory CALLIPER analysis found that vidofludimus calcium significantly reduced EBV-specific TCRβ chain (TRB) sequence matches versus placebo-treated patients (-0.65 matches; p=0.0004), while influenza A-specific matches were unchanged (+0.08; p=0.5983), suggesting an EBV-selective rather than generalized effect on the T-cell repertoire, consistent with a lowered rate of EBV reactivations. Across all patients, reductions in EBV-specific TRB matches were associated with improved Symbol Digit Modalities Test (SDMT, broadly used to assess processing speed) scores, as assessed in a post-hoc analysis. Safety and tolerability data from the CALLIPER trial are summarized below.
These exploratory findings support further investigation of the relationship between EBV-related immune activity and cognitive function in progressive MS.
Novel CALLIPER Analyses Evaluate Disability Improvement and Worsening Together
Poster Title: Bidirectional Disability Changes in Progressive Multiple Sclerosis Patients: a Proposed Endpoint to Capture Full Treatment Effects
- Lead Author: James Myles, Global Head of Biostatistics at Immunic
- Presentation: ePoster, Number EP2205
- Date and Time: ePoster screens within the congress center and on the congress platform for the duration of the congress
Traditional progressive MS analyses have focused primarily on delaying confirmed disability worsening, with improvement often not captured fully or assessed separately. This analysis evaluates two novel statistical models, Confirmed Disability Change (CDC) and Generalized Pairwise Comparisons (GPC), as proposed methods to integrate confirmed disability worsening and improvement into a single statistical analysis measure.
Applying both methods to CALLIPER post-hoc, progressive MS patients treated with vidofludimus calcium appeared more likely to have positive outcomes as compared to placebo, suggesting these methods may capture the true bidirectional disability trajectory of patients. The CDC method fits an ordinal logistic regression model to three ordered categories of confirmed disability change. Using data from the CALLIPER trial, patients treated with vidofludimus calcium were 2.47 times more likely to experience 24-week confirmed disability improvement (CDI) (nominal p=0.037), and a positive CDC (nominal p=0.042). The GPC method compares all pairs of patients to determine which patient had a better outcome as measured by improvement, stability, or slowed worsening on the Expanded Disability Status Scale (EDSS) score. By this method, patients on vidofludimus calcium were 1.5 times more likely to have a better outcome than those who received placebo, a statistically significant and clinically meaningful result (p=0.042).
These outcomes support further evaluation of a bidirectional endpoint designed to capture treatment effects across both disability worsening and improvement.
About Vidofludimus Calcium (IMU-838) and the CALLIPER Trial
Vidofludimus calcium (IMU-838) is an investigational oral small molecule activating nuclear receptor-related 1 (Nurr1) and selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). It is currently being evaluated in the Phase 3 ENSURE trials in relapsing multiple sclerosis (MS). More than 3,500 individuals have been exposed to vidofludimus calcium, to date.
The Phase 2 CALLIPER trial randomized 467 patients with primary or secondary progressive MS 1:1 to 45 mg once-daily vidofludimus calcium or placebo. While the primary endpoint of percent brain volume change (PBVC) was not met, exploratory imaging and clinical outcomes showed directionally favorable signals. Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were similar to placebo (69.4% vs. 68.5% and 8.1% vs. 6.5%, respectively), with no new safety signals and no Hy's law range cases observed. Among the 387 participants who entered the OLE phase, 44.4% experienced at least one TEAE, including 5.7% who experienced a serious TEAE. Liver-related TEAEs occurred in 3.1% of participants, and TEAEs leading to discontinuation in 1.8%.
Vidofludimus calcium (IMU-838) is an investigational medicinal product that has not been approved or authorized by the U.S.