NEW YORK, May 28, 2026
Immunic, Inc. has unveiled new analyses from its Phase 2 CALLIPER trial evaluating vidofludimus calcium (IMU-838) in patients with Progressive Multiple Sclerosis (PMS), further strengthening the therapy’s potential as a novel treatment option for one of the most challenging forms of multiple sclerosis. Presented at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting in Charlotte, North Carolina, the new data include a late-breaking statistical analysis, patient-reported outcomes, and long-term safety findings. Together, the results reinforce vidofludimus calcium’s differentiated clinical profile, highlighting potential neuroprotective effects, favorable tolerability, and sustained patient well-being over treatment periods extending up to 120 weeks.
Novel Disability Analysis Suggests Potential Neuroprotective Benefits
A key highlight of the CMSC presentations is a late-breaking analysis introducing a new Confirmed Disability Change (CDC) endpoint, designed to provide a more comprehensive assessment of disease progression in progressive multiple sclerosis. Traditionally, clinical trials have focused primarily on confirmed disability worsening, potentially overlooking meaningful improvements experienced by patients. The new CDC framework integrates both confirmed disability worsening (CDW) and confirmed disability improvement (CDI) into a unified statistical model.
Researchers applied three advanced statistical approaches, including ordinal categorical analysis, time-to-event modeling, and Markov state change modeling, to data from the CALLIPER study. Across all methods, results consistently favored vidofludimus calcium over placebo, suggesting that the investigational therapy may influence both slowing disease progression and promoting functional improvement. Investigators believe this integrated approach may provide a more accurate picture of patient outcomes and could potentially improve the design and sensitivity of future progressive multiple sclerosis clinical trials.
The findings are particularly important because progressive MS remains an area of significant unmet medical need, with limited therapies capable of addressing long-term neurological decline. By capturing both deterioration and improvement, the new methodology may help identify therapies with genuine neuroprotective potential.
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Patient-Reported Outcomes Support Quality of Life Benefits
In addition to disability-related assessments, Immunic presented data evaluating patient-reported outcomes (PROs) from the CALLIPER trial. These analyses focused on measures of depressive symptoms, treatment satisfaction, and overall patient experience throughout the study period.
Importantly, results demonstrated no evidence of worsening depression, mood disturbances, or suicidal thoughts among patients receiving vidofludimus calcium compared with placebo over 120 weeks of treatment. Changes in Patient Health Questionnaire-9 (PHQ-9) scores remained similar between treatment groups, while numerical improvements were observed across multiple assessment time points.
Treatment satisfaction measures also favored vidofludimus calcium. Patients reported higher perceived treatment effectiveness compared with placebo at both 48 and 120 weeks, while side-effect burden remained comparable between groups. These findings suggest that patients experienced meaningful clinical benefits without compromising emotional well-being or treatment tolerability, factors that are increasingly recognized as critical components of long-term disease management.
The ability to maintain stable mood and quality-of-life measures is particularly relevant in progressive MS, where physical disability, fatigue, and psychological challenges often contribute substantially to disease burden.
Long-Term Safety Data Reinforce Favorable Risk-Benefit Profile
Safety and tolerability findings from the CALLIPER study further support continued development of vidofludimus calcium. The analysis included 467 patients treated for up to 120 weeks, providing one of the most comprehensive safety evaluations of the investigational therapy to date.
The incidence of treatment-emergent adverse events was nearly identical between the vidofludimus calcium and placebo groups. Common events such as urinary tract infections, headache, and back pain occurred at similar or lower frequencies among treated patients. Importantly, adverse events leading to treatment discontinuation were low and identical across both groups.
Liver-related adverse events remained uncommon, with no cases meeting criteria associated with severe drug-induced liver injury. Serious adverse events were reported at low and comparable rates, while infection and renal event rates remained consistent between treatment arms. These findings align with previous clinical studies and further reinforce the therapy’s favorable long-term safety profile.
Vidofludimus calcium combines Nurr1 activation, which is associated with neuroprotective mechanisms, with selective DHODH inhibition, providing anti-inflammatory and antiviral activity. This unique dual mechanism continues to distinguish the therapy within the multiple sclerosis treatment landscape. As Immunic advances ongoing late-stage development programs, the latest CALLIPER data provide additional evidence supporting the potential role of vidofludimus calcium as a next-generation therapy for progressive multiple sclerosis and a promising candidate capable of addressing both disease progression and patient quality of life.
Source: Immunic press release
