Immunic Presented Key Vidofludimus Calcium Data at the 41st Congress of ECTRIMS, Highlighting Its Potential in Multiple Sclerosis
Immunic (NASDAQ:IMUX) presented key data for vidofludimus calcium in multiple sclerosis at the 41st ECTRIMS Congress. The phase 2 CALLIPER trial demonstrated statistically significant results in progressive multiple sclerosis, showing over two-fold probability of 24-week confirmed disability improvement versus placebo.
The drug reduced the risk of 24-week confirmed disability worsening by 23.8% versus placebo in the overall population and by 33.7% in patients without gadolinium-enhancing lesions. Long-term data from the Phase 2 EMPhASIS trial in relapsing-remitting MS showed 92.3% of patients remained free of 12-week confirmed disability worsening at week 144, with favorable safety profiles.
Immunic (NASDAQ:IMUX) ha presentato dati chiave su vidofludimus calcium per la sclerosi multipla al 41° Congresso ECTRIMS. Lo studio di fase 2 CALLIPER ha mostrato risultati statisticamente significativi nella sclerosi multipla progressiva, evidenziando una probabilità di miglioramento della disabilità confermata a 24 settimane superiore al doppio rispetto al placebo.
Il farmaco ha ridotto il rischio di peggioramento della disabilità confermata a 24 settimane di 23,8% rispetto al placebo nell'intera popolazione e di 33,7% nei pazienti senza lesioni gadolinio-Enhancing. I dati a lungo termine dello studio di fase 2 EMPhASIS nella sclerosi multipla recidivante-remittente hanno indicato che il 92,3% dei pazienti è rimasto libero da peggioramenti della disabilità confermati a 12 settimane fino alla settimana 144, con profili di sicurezza favorevoli.
Immunic (NASDAQ:IMUX) presentó datos clave sobre vidofludimus calcium para la esclerosis múltiple en el 41.º Congreso ECTRIMS. El ensayo de fase 2 CALLIPER mostró resultados estadísticamente significativos en la esclerosis múltiple progresiva, con una probabilidad de mejora confirmada de la discapacidad a 24 semanas superior al doble que el placebo.
El fármaco redujo el riesgo de empeoramiento de la discapacidad confirmada a 24 semanas en un 23,8% frente al placebo en la población general y en un 33,7% en pacientes sin lesiones que presenten gadolinio. Los datos a largo plazo del ensayo de fase 2 EMPhASIS en esclerosis múltiple remitente-recurrente mostraron que el 92,3% de los pacientes permanecieron libres de empeoramiento de la discapacidad confirmado a 12 semanas hasta la semana 144, con perfiles de seguridad favorables.
Immunic (NASDAQ:IMUX)는 41번째 ECTRIMS 학술대회에서 다발성 경화증에 대한 vidofludimus calcium의 주요 데이터를 발표했습니다. 2상 CALLIPER 연구는 진행성 다발성 경화증에서 통계적으로 유의한 결과를 보여주었고, 24주 확인된 장애 개선의 확률이 위약보다 두 배 이상 높았습니다.
약물은 전체 인구에서 24주 확인된 장애 악화 위험을 23.8% 감소시켰고, 가돌리늄 강화 병변이 없는 환자에서 33.7% 감소를 보였습니다. 재발-완화형 다발성 경화증의 2상 EMPhASIS 연구의 장기 데이터에 따르면 144주까지 12주 확인된 장애 악화가 없는 환자는 92.3%였고, 안전성 프로파일도 우수했습니다.
Immunic (NASDAQ:IMUX) a présenté des données clés sur le vidofludimus calcium dans la sclérose en plaques lors du 41e Congrès ECTRIMS. L’essai de phase 2 CALLIPER a démontré des résultats statistiquement significatifs dans la sclérose en plaques progressive, avec une probabilité de amélioration confirmée de l’incapacité à 24 semaines supérieure à celle du placebo.
Le médicament a réduit le risque d’aggravation confirmée de l’incapacité à 24 semaines de 23,8% vs placebo dans l’ensemble de la population et de 33,7% chez les patients sans lésions augmentées par gadolinium. Les données à long terme de l’essai de phase 2 EMPhASIS dans la sclérose en plaques récurrente-rémittente montrent que 92,3% des patients sont restés libres d’aggravation de l’incapacité confirmée à 12 semaines jusqu’à la semaine 144, avec des profils de sécurité favorables.
Immunic (NASDAQ:IMUX) präsentierte beim 41. ECTRIMS-Kongress wichtige Daten zu Vidofludimus-Calcium bei Multipler Sklerose. Die Phase-2-Studie CALLIPER zeigte statistisch signifikante Ergebnisse bei der fortschreitenden MS und eine über zwei Mal so hohe Wahrscheinlichkeit einer 24-Wochen-bestätigten Behinderungsverbesserung im Vergleich zu Placebo.
Das Medikament senkte das Risiko einer 24-Wochen-bestätigten Verschlechterung der Behinderung in der Gesamtpopulation um 23,8% gegenüber Placebo und bei Patienten ohne gadolinium-aufgelistete Läsionen um 33,7%. Langzeitdaten der Phase-2-EMPhASIS-Studie bei schubförmiger MS zeigten, dass 92,3% der Patienten bis Woche 144 frei von einer 12-Wochen-bestätigten Verschlechterung der Behinderung blieben, mit günstigen Sicherheitsprofilen.
Immunic (NASDAQ:IMUX) قدمت بيانات رئيسية عن vidofludimus calcium في التصلب المتعدد ضمن المؤتمر الحادي والأربعين ECTRIMS. أظهر تجربة المرحلة 2 CALLIPER نتائج ذات دلالة احصائية في التصلب المتعدد التدريجي، مع احتمال تفوق مزدوج في التحسن المؤكد للإعاقة خلال 24 أسبوعًا مقارنةً بالدواء الوهمي.
خفض الدواء خطر تدهور الإعاقة المؤكَّد خلال 24 أسبوعًا بمقدار 23.8% مقارنةً بالدواء الوهمي في المجموعة الكلية وبـ 33.7% لدى المرضى بدون آفات تتفاقم بواسطة gadolinium. أظهرت البيانات طويلة الأمد من تجربة المرحلة 2 EMPhASIS في التصلب المتعدد المعاود/المتكرر أن 92.3% من المرضى ظلوا خاليين من تدهور الإعاقة المؤكَّد خلال 12 أسبوعًا حتى الأسبوع 144، مع ملفات أمان واعدة.
Immunic (NASDAQ:IMUX)在第41届ECTRIMS大会上公布了 vidofludimus calcium 对多发性硬化症的关键数据。2期 CALLIPER 试验在进展性MS中显示了统计学上显著的结果，24周确认的残疾改善概率比安慰剂高出两倍以上。
该药物在总体人群中把24周确认的残疾恶化风险降低了23.8%，在无钆增强病变的患者中降幅为33.7%。2期 EMPhASIS 试验针对复发-缓解型MS的长期数据表明，至第144周，92.3%的患者在12周确认的残疾恶化方面保持自由，且安全性良好。
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Insights
Immunic's vidofludimus calcium shows promising disability improvement in progressive MS trials, with strong safety profile and neuroprotective mechanism.
The phase 2 CALLIPER trial results for vidofludimus calcium represent a significant development in progressive multiple sclerosis (PMS) treatment, where effective therapies remain limited. The drug demonstrated a 23.8% reduction in 24-week confirmed disability worsening versus placebo in the overall PMS population, with an even stronger 33.7% reduction in patients without gadolinium-enhancing lesions at baseline.
Most impressive is the statistically significant improvement in 24-week confirmed disability improvement (24wCDI) with a hazard ratio of 2.441 (p=0.034) in the overall population. This means patients taking vidofludimus calcium had over twice the probability of experiencing disability improvement compared to placebo - a remarkable finding in progressive forms of MS where improvement is rarely seen.
The consistent effects across MS subtypes, including primary progressive MS (PPMS) and non-active secondary progressive MS (naSPMS), suggest vidofludimus calcium's mechanism as a Nurr1 activator may provide neuroprotection independent of anti-inflammatory effects. This is supported by efficacy in patients without evidence of inflammatory activity, addressing a critical unmet need.
The long-term extension data from the EMPhASIS trial in relapsing-remitting MS further strengthens the clinical profile, with 92.3% of patients remaining free of 12-week confirmed disability worsening and 92.7% free of 24-week confirmed disability worsening at 144 weeks. The low discontinuation rate (
The preclinical models demonstrating increased brain-derived neurotrophic factor (BDNF) and reduced neurofilament light chain (NfL) provide mechanistic support for the clinical findings. With phase 3 ENSURE trials fully enrolled and data expected by end of 2026, vidofludimus calcium shows promise as a differentiated oral therapy with both anti-inflammatory and neuroprotective properties for multiple sclerosis patients.
The CALLIPER trial results position vidofludimus calcium as a potentially transformative treatment for progressive MS forms where therapeutic options remain severely limited. The data revealed several compelling metrics that strengthen Immunic's competitive position:
First, the statistically significant 24-week confirmed disability improvement (24wCDI) with over 2.4 times higher probability versus placebo represents a breakthrough finding. In progressive MS, merely slowing deterioration is typically considered successful - actually improving function is exceptional.
Second, the drug's efficacy in patients without gadolinium-enhancing lesions (33.7% risk reduction in disability progression) demonstrates a potential competitive advantage. Most existing MS therapies primarily target inflammatory activity, leaving patients without active inflammation with few options. This suggests vidofludimus calcium could address an underserved market segment.
The consistent efficacy signals across both PPMS and naSPMS subtypes position the drug to potentially target multiple progressive MS indications, expanding its commercial opportunity. The selection for the "Best of ECTRIMS 2025" slide deck indicates recognition from key opinion leaders in the field.
From a market perspective, the differentiated mechanism combining Nurr1 activation with selective DHODH inhibition creates a unique product profile that could support premium pricing if approved. The oral administration route maintains convenience while the clean safety profile (with up to 5.5 years of data showing low discontinuation rates) addresses a key concern with existing therapies.
With the fully enrolled twin phase 3 ENSURE trials in relapsing MS expected to read out by end of 2026, Immunic has multiple shots on goal across different MS subtypes. The robust phase 2 data package has substantially de-risked a potential phase 3 program in progressive MS, creating an additional value driver beyond the ongoing relapsing MS program.
– Vidofludimus Calcium Demonstrated Statistically Significant 24-Week Confirmed Disability Improvement in Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis, With Over Two-Fold Probability Over Placebo in the Overall Study Population and Consistent Effects Across Subtypes –
– CALLIPER Data Showed Positive and Consistent Signals for Slowing Disability Progression Across Disability Endpoints, Patient Populations and Subgroups Without Evidence of Focal Inflammation, Reinforcing the Drug's Neuroprotective Potential and Promise to Slow Disease Progression –
– CALLIPER Data Supports Nurr1 Activation as New Mechanism to Prevent Neurodegeneration in Multiple Sclerosis –
– Long-Term Data From Phase 2 EMPhASIS Trial in Relapsing-Remitting Multiple Sclerosis Showed High Rates of Patients Remaining Free of 12- and 24-Week Confirmed Disability Worsening as well as Low Discontinuation Rates and Favorable Long-Term Safety and Tolerability –
"Having such a broad presence at the prestigious ECTRIMS Congress is a major achievement for Immunic and underscores both the strength of our clinical and preclinical data and the potential of vidofludimus calcium to transform the oral MS therapy landscape," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We were especially honored to showcase, in an oral presentation, the positive efficacy and safety data from our phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), offering much needed hope for this high unmet medical need patient population."
Dr. Vitt continued, "The CALLIPER results, also selected for the Best of ECTRIMS 2025 slide deck, highlight vidofludimus calcium's neuroprotective potential and its promise to slow disease progression in patients with or without focal inflammation. Importantly, the consistent 24-week confirmed disability worsening (24wCDW) results across disability endpoints, patient populations and subgroups, including in patients without evidence of baseline inflammatory gadolinium-enhancing (Gd+) lesions during MRI, were seen both in the overall population and in the primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (naSPMS) subgroups. Additionally, newly available data regarding 24-week confirmed disability improvement (24wCDI) showed an over two-fold probability for vidofludimus calcium over placebo, statistically significant in the overall PMS population, with consistent trends across the subtypes. The CALLIPER findings support clinically measurable neuroprotective effects of vidofludimus calcium, consistent with its Nurr1 activation mechanism. We believe that, since 24wCDW is an accepted regulatory endpoint to demonstrate clinical benefit in PMS, this evidence of clinical activity merits further investigation and de-risks a potential phase 3 program."
"Moreover, additional long-term data from our phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) has further reinforced the robust efficacy signals and favorable safety and tolerability observed, to date," concluded Dr. Vitt. "Importantly, our fully enrolled twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for which top-line data is expected by the end of 2026, are designed to evaluate multiple endpoints regarding patient disability. With its unique neuroprotective, anti-inflammatory, and anti-viral profile, along with clean safety and tolerability observed in clinical trials to date, we believe vidofludimus calcium has the potential to become a differentiated oral therapy in the multi-billion-dollar MS market."
Oral Presentation:
- Title: Efficacy and Safety of Vidofludimus Calcium, a Novel Nurr1 Activator and Selective DHODH Inhibitor, in Progressive Multiple Sclerosis: Data from the Phase 2 CALLIPER Trial
- Presenting 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 - Abstract Number: ECTRIMS25-1404
- Presentation ID: O024
- Selected for the 'Best of ECTRIMS 2025' slide deck
In the overall PMS population (n=467), treatment with vidofludimus calcium reduced the risk of 24wCDW, as assessed by the Expanded Disability Status Scale (EDSS), by
"In the phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis patients, we observed consistent trends suggesting a reduction in disability progression across multiple outcomes, patient populations, and subgroups, including those without gadolinium-enhancing lesions at baseline," stated Dr. Fox. "These findings support the hypothesis that Nurr1 activation may represent a novel mechanism to prevent neurodegeneration in MS. Further, vidofludimus calcium demonstrated a favorable safety and tolerability profile, with similar rates of adverse event rates compared to placebo and no new safety signals at the 45 mg once-daily dose. Overall, the CALLIPER trial data support advancing vidofludimus calcium into phase 3 studies for PMS."
Late Breaking Poster Presentation:
- Title: Efficacy and Safety of Vidofludimus Calcium, a Novel Nurr1 Activator and DHODH Inhibitor, in Primary Progressive Multiple Sclerosis (PPMS): Subpopulation Data from the Phase 2 CALLIPER Trial
- Presenting 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 - Abstract Number: IMS25-LBA-317
- Poster Number: P417
In the PPMS subpopulation of the CALLIPER trial, vidofludimus calcium demonstrated trends toward reducing disability progression. Results for 24wCDW based on EDSS showed hazard ratios of 0.687 for the overall PPMS population and 0.656 for the subpopulation of patients without baseline Gd+ lesions. These findings support the potential neuroprotective effects of vidofludimus calcium, likely through Nurr1 activation, and merit further investigation in phase 3 trials.
Poster Presentations:
- Title: 144-Week Analysis of the Confirmed Disability Worsening Events in the Open-Label Treatment Extension of the Phase 2 EMPhASIS Study of Vidofludimus Calcium in Patients with Relapsing-Remitting Multiple Sclerosis
- Presenting Author: Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic
- Abstract Number: ECTRIMS25-1587
- Poster Number: P814
At week 144 of the phase 2 EMPhASIS open-label extension (OLE) period,
- Title: Update on the Assessment of Long-Term Safety and Tolerability of Vidofludimus Calcium in Patients with Relapsing-Remitting Multiple Sclerosis in the Open-Label Extension Period of the Phase 2 EMPhASIS Trial
- Presenting 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 EMPhASIS trial - Abstract Number: ECTRIMS25-191
- Poster Number: P834
Long-term data from the phase 2 EMPhASIS OLE period demonstrated that vidofludimus calcium was well-tolerated in patients with RRMS for treatment durations of up to 5.5 years. Among 182 patients remaining on therapy as of January 14, 2025, cumulative exposure totaled approximately 952 treatment years, with an annualized discontinuation rate of only approximately
- Title: Potential Neuroprotective Activity by Vidofludimus Calcium in In Vivo Models of Multiple Sclerosis
- Presenting Author: Evelyn Peelen, Ph.D., Head of Research at Immunic
- Abstract Number: ECTRIMS25-1142
- Poster Number: P167
In a preclinical mouse model of multiple sclerosis (experimental autoimmune encephalomyelitis, EAE), both prophylactic and therapeutic treatment with vidofludimus calcium effectively attenuated disease severity. Treatment reduced T cell infiltration into the central nervous system (CNS), including decreased number of pathogenic T helper cells producing interleukin-17A (IL-17A), granulocyte-macrophage colony-stimulating factor (GM-CSF), and interferon gamma (IFNγ). Prophylactic dosing also increased expression of Nurr1 target genes in the CNS, elevated plasma brain-derived neurotrophic factor (BDNF) levels, and reduced plasma neurofilament light chain (NfL) levels. In a small EAE pilot study, vidofludimus calcium reduced expression of the microglial activation marker Iba-1 and the neuronal injury marker APP, while increasing expression of the myelin marker MBP. These findings support vidofludimus calcium's potential Nurr1-mediated neuroprotective activity.
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 biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune 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
Contact Information
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FAQ
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