Immunic to Present New Clinical, Biomarker and Preclinical Data on Vidofludimus Calcium at MSToronto2026 - the 10th Joint ACTRIMS-ECTRIMS Meeting
Continuous-treatment disability outcomes remained favorable through extension week 48, while biomarker findings were exploratory.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Immunic (IMUX) will present four abstracts on investigational vidofludimus calcium at MSToronto2026 in Toronto, October 21–23, 2026.
Phase 2 CALLIPER open-label extension data favored continuous treatment over switching from placebo for disability outcomes through extension week 48. Trends toward lower risk of 24-week confirmed disability worsening persisted, improvement occurred more frequently, and discontinuation remained low.
A post-hoc analysis found significantly reduced Epstein-Barr virus-specific immune signatures versus placebo; reductions across both treatment arms were associated with better cognitive test performance. Preclinical findings linked neuronal survival to Nurr1, a protein involved in gene regulation. A proposed measure combining disability worsening and improvement produced statistically significant CALLIPER results, with similar findings using another statistical method.
Positive
- Minor pointCALLIPER disability outcomes favored continuous treatment through extension week 48 over switching from placebo.
- Minor pointTreatment discontinuation remained low, with a high proportion entering the CALLIPER open-label extension.
- Minor pointEBV-specific T-cell receptor signatures declined significantly versus placebo; influenza A-specific signatures were unchanged.
- Minor pointEBV-signature reductions across both treatment arms were associated with improved cognitive performance, primarily in primary progressive MS.
- Minor pointPreclinical neuronal survival increased under stress in human cells; the effect required Nurr1.
3 minor points
- Minor pointMicroglia-driven neuronal loss was attenuated in preclinical testing.
- Minor pointMouse models showed reduced disease severity, increased Nurr1-regulated gene expression and reduced plasma neurofilament light chain.
- Minor pointCombined disability-change analysis yielded statistically significant CALLIPER results, with similar findings using Generalized Pairwise Comparisons.
Negative
- Minor pointEBV and cognition findings came from an exploratory, post-hoc CALLIPER analysis.
- Minor pointCombined disability-change endpoint remains proposed and requires further evaluation.
Key Figures
- Accepted abstracts
- 4 abstracts
- Accepted for presentation at MSToronto2026
- CALLIPER trial phase
- Phase 2
- Vidofludimus calcium study in progressive MS
- Open-label extension follow-up
- Week 48
- Disability outcomes favoring continuous treatment were maintained through the extension
- Confirmed disability worsening window
- 24 weeks
- CALLIPER analysis reported a maintained trend toward lower risk
Key Terms
nurr1 medical
open-label extension medical
experimental autoimmune encephalomyelitis medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– Four Accepted Abstracts Further Characterize Investigational Vidofludimus Calcium's Profile in Multiple Sclerosis Across Long-Term Disability Outcomes, EBV-Related Immune Activity and Cognition, Novel Disability Measurement, and Nurr1-Mediated Neuronal Survival –
– New Phase 2 CALLIPER Open-Label Extension Data Show Disability Outcomes Favoring Continuous Vidofludimus Calcium Treatment Maintained Through Extension Week 48, With Low Treatment Discontinuation –
"The four presentations at MSToronto2026 add to the growing 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. "The new CALLIPER open-label extension outcomes provide favorable long-term follow-up data of disability outcomes in progressive MS, while the Nurr1, Epstein-Barr virus (EBV) and disability endpoint analyses further deepen our understanding of vidofludimus calcium's potential to address both inflammatory disease activity and disability progression. We look forward to presenting these findings to the MS community later this month."
Details of the Immunic Presentations at MSToronto2026:
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
Analyses of the phase 2 CALLIPER trial in progressive MS that included the open-label extension (OLE) phase evaluate long-term disability outcomes, comparing participants who received continuous vidofludimus calcium with those who switched from placebo at OLE entry. A high proportion of patients transitioned to the OLE phase from the double-blind period and discontinuation rates remained low. Trends towards a lower risk of 24-week confirmed disability worsening were maintained, while confirmed disability improvement occurred more frequently.
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 and protects neurons. In human neuronal cells, vidofludimus calcium increased survival under apoptotic stress, an effect abolished by Nurr1 knockout, indicating that Nurr1 is required for its direct pro-survival activity in vitro. Vidofludimus calcium also attenuated microglia-driven neuronal loss. Consistent with its dual mode of action, vidofludimus calcium reduced disease severity, increased Nurr1-regulated gene expression in vivo and reduced plasma neurofilament light chain in experimental autoimmune encephalomyelitis (EAE) models.
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
In this post-hoc CALLIPER analysis, vidofludimus calcium significantly reduced EBV-specific T-cell receptor signatures versus placebo-treated patients, consistent with a lowered rate of EBV reactivations, while influenza A-specific signatures were unchanged. Across both treatment arms, reductions in EBV-specific signatures were associated with improved performance on the Symbol Digit Modalities Test (SDMT), primarily driven by participants with primary progressive MS. These exploratory findings support further investigation of the relationship between EBV-related immune activity and cognitive function in progressive MS.
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 trial endpoints generally focus on disability worsening and may not fully capture disability improvement. This analysis evaluates confirmed disability change (CDC), a proposed endpoint integrating confirmed disability worsening and improvement into a single statistical analysis measure. Statistically significant CDC results were observed using data from the CALLIPER trial. This result was also evaluated using the Generalized Pairwise Comparisons (GPC) methodology with similar results. The GPC methodology has been used in other disease settings to address multiple endpoints. These outcomes support further evaluation of a bidirectional endpoint designed to capture treatment effects across both disability worsening and improvement.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently being evaluated in Phase 3 clinical trials for the treatment of relapsing multiple sclerosis, with top-line data expected to be available by the end of 2026. Initiation of an additional Phase 3 clinical trial in progressive MS is expected later in 2026. Vidofludimus calcium has already shown therapeutic potential and a favorable safety and tolerability profile in Phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-381 and IMU-856, aimed at building a broader therapeutics platform addressing neurodegenerative and autoimmune diseases. For further information, please visit: www.imux.com.
Vidofludimus calcium (IMU-838) is an investigational medicinal product that has not been approved or authorized by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other regulatory authority for any indication in any jurisdiction. Its safety and efficacy have not been established. Any clinical, biomarker, or preclinical findings described reflect investigational data and are not intended to suggest that vidofludimus calcium is safe or effective for any use.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory Phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
LifeSci Advisors
Joyce Allaire
immunic@lifesciadvisors.com
US Media Contact
Real Chemistry
media@imux.com
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SOURCE Immunic, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Immunic's CALLIPER extension data show for vidofludimus calcium?
Disability outcomes favored continuous vidofludimus calcium treatment through extension week 48 compared with switching from placebo at extension entry. Trends toward lower risk of 24-week confirmed disability worsening were maintained, confirmed disability improvement occurred more frequently, and treatment discontinuation remained low.
What did Immunic's CALLIPER analysis find about EBV and cognition?
Vidofludimus calcium significantly reduced Epstein-Barr virus-specific T-cell receptor signatures versus placebo in a post-hoc analysis. Across both treatment arms, reductions were associated with improved Symbol Digit Modalities Test performance, primarily among participants with primary progressive multiple sclerosis. These findings were exploratory.
How did Immunic test whether Nurr1 was required for vidofludimus calcium's neuronal survival effect?
Removing Nurr1 abolished vidofludimus calcium's survival-promoting effect in human neuronal cells under apoptotic stress, a condition that triggers cell death. This indicated that Nurr1 was required for the direct survival effect in laboratory cell testing.