Immunic to Present Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the ACTRIMS Forum 2026, Reinforcing Its Potential in Progressive Multiple Sclerosis
– Additional CALLIPER MRI Analyses Show Reductions for Vidofludimus Calcium in Acute and Chronic Inflammatory Disease Activity –
– CALLIPER Subset Data Demonstrate Reductions in EBV-Specific T-Cell Receptor Sequences, Underlining Broad-Spectrum Antiviral Effects of Vidofludimus Calcium –
NEW YORK, Feb. 4, 2026 /PRNewswire/ -- Immunic, Inc. (NASDAQ:IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced the presentation of additional data from its phase 2 CALLIPER trial evaluating lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026, taking place from February 5-7, in San Diego, California. Both poster presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, members of Immunic's management, medical and preclinical teams will be available throughout the event at booth #N9.
"Together, our two poster presentations at the prestigious ACTRIMS Forum further underscore the unique mechanism of action of vidofludimus calcium and its potential in PMS," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "These latest findings from our phase 2 CALLIPER trial provide additional evidence of vidofludimus calcium's effects on key biological drivers of disease progression, including antiviral immune responses linked to Epstein-Barr virus (EBV) and magnetic resonance imaging (MRI) markers of both acute-focal and chronic-compartmentalized inflammation. The findings further reinforce our belief that vidofludimus calcium has the potential to address underlying mechanisms of disease progression in multiple sclerosis (MS) patients."
Presentation Details:
- Poster Title: Effect of Vidofludimus Calcium, a Novel Nurr1 Activator and Selective DHODH Inhibitor, on MRI Outcomes in Progressive Multiple Sclerosis: Data from the Phase 2 CALLIPER Trial
- Presenting Author: Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic
- Abstract Number: 555
- Poster Number: P130
- Poster Session: 1
- Session Date: Thursday, February 5, 2026
- Session Time: 5:45 pm – 7:30 pm PT (even-numbered posters present from 6:00-6:45 pm)
MRI lesions in the brain of MS patients are commonly understood to be markers of acute-focal inflammation. In patients with PMS enrolled in the phase 2 CALLIPER trial, treatment with vidofludimus calcium was associated with improvements across key MRI markers of both acute-focal and chronic-compartmentalized inflammation when compared to placebo.
The proportion of patients in the vidofludimus calcium group with gadolinium-enhancing (Gd+) lesions decreased from 16.4% at baseline (placebo: 16.4%) to 7.0% at week 72 (placebo: 11.7%) and 0% at week 120 (placebo: 2.9%). At week 72, the proportion of patients with new and/or enlarging T2 lesions was 18.5% for those in the vidofludimus calcium group vs. 30.0% for those in the placebo group. The difference in the mean change of T2 lesion volume in favor of vidofludimus calcium was statistically significant for weeks 48 (p<0.05), 72 (p<0.005), and 96 (p<0.05). Additionally, the difference in the number of slowly expanding lesions (SEL), an emergent indicator of chronic-compartmentalized inflammation in PMS patients, was statistically significant at week 96 between the vidofludimus calcium and placebo groups, with least squares means of 2.935 and 3.840 (p<0.05).
"These new MRI results from our phase 2 CALLIPER trial show evidence that vidofludimus calcium reduces radiographic hallmarks of both acute-focal and chronic-compartmentalized inflammation in patients with PMS," stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic. "The observed reductions further support the potential of vidofludimus calcium to influence compartmentalized central nervous system inflammation, which is believed to contribute to disability progression, in this progressive patient population."
Presentation Details:
- Poster Title: Effect of Vidofludimus Calcium, a Novel Nurr1 Activator and DHODH Inhibitor, on the Anti-EBV T-cell Receptor Repertoire in Progressive Multiple Sclerosis: Data from the Phase 2 CALLIPER Trial
- Presenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development at Immunic
- Abstract Number: 411
- Poster Number: P024
- Poster Session: 1
- Session Date: Thursday, February 5, 2026
- Session Time: 5:45 pm – 7:30 pm PT (even-numbered posters present from 6:00-6:45 pm)
This poster presents data on the antiviral effects of vidofludimus calcium, specifically regarding EBV, a chronic viral infection known to be a precondition for MS and hypothesized to also play a role in disease progression.
In a subset of 87 phase 2 CALLIPER trial participants with PMS (44 placebo, 43 vidofludimus calcium), treatment effects on EBV reactivation before and during treatment were evaluated for vidofludimus calcium compared to placebo from day 1 through week 48. The applied methodology of measuring the so-called T-cell receptor (TCR) repertoire explores the overall diversity and composition of T-cell receptors. The sequences targeted against EBV-specific antigens were compared with Influenza A-virus (IAV) antigen targeted sequences as control. The presence of these matched sequences in the TCR repertoire is believed to reflect ongoing interaction of T-cells with these specific viruses, and, hence, are thought to be a reflection of ongoing active viral infection. EBV causes a chronic life-long virus infection with the general understanding that interactions between its antigens and T-cells are ordinarily restricted to periods of virus reactivations.
For tested CALLIPER patients on placebo, the EBV-specific matches remained stable over time, indicating persistent exposure of T-cells to EBV during the study. In contrast, patients treated with vidofludimus calcium showed a progressive decline of EBV-specific matches over time, consistent with a lowering of the rate of EBV reactivations during treatment. The comparison of actively treated and untreated patients was statistically significant (p=0.0004). For IAV-related matches used as control, no statistically significant change was observed between the groups.
"These findings from a subset of the phase 2 CALLIPER trial participants strengthen our hypothesis that the broad-spectrum antiviral effects of vidofludimus calcium can lead to lower EBV reactivations, potentially addressing MS disease progression related to ongoing EBV reactivations," added Dr. Muehler. "The findings warrant further investigation of the possible correlations between clinical outcomes of the CALLIPER trial and the anti-EBV T-cell response in patients."
About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is an orally administered investigational small molecule drug being developed for chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis (MS). Uniquely, vidofludimus calcium's first-in-class, dual mode of action combines neuroprotective, anti-inflammatory and anti-viral effects to target the complex pathophysiology of MS. As a selective immune modulator, it activates the neuroprotective transcription factor, nuclear receptor-related 1 (Nurr1), which provides direct and indirect neuroprotective effects. Additionally, vidofludimus calcium achieves anti-inflammatory and anti-viral effects through highly selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium is currently being evaluated in phase 3 clinical trials for the treatment of relapsing MS. In a phase 2 clinical trial, it has shown therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. Additionally, vidofludimus calcium has demonstrated clinical benefits in progressive MS patients by showing substantial reductions in confirmed disability worsening and thalamic brain volume in a phase 2 clinical trial. To date, vidofludimus calcium has been exposed to approximately 2,700 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country.
About Immunic, Inc.
Immunic, Inc. (NASDAQ:IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. 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). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.
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 timing of current and future clinical trials and anticipated clinical milestones; 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, and the ability to raise sufficient capital to continue as a going concern, 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, 2024, filed with the SEC on March 31, 2025, 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.
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