Immunic Presents Key Vidofludimus Calcium Data at the ACTRIMS Forum 2025, Highlighting Its Potential in Multiple Sclerosis
Immunic (Nasdaq: IMUX) presented key data on its lead asset vidofludimus calcium (IMU-838) at the ACTRIMS Forum 2025 through two poster presentations. The first presentation analyzes baseline characteristics of patients in subpopulations from the phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), comparing them with four major PMS trials.
The company expects top-line data from the CALLIPER trial in April, which will evaluate vidofludimus calcium's effects on 24-week confirmed disability worsening in non-active PMS patients. The second poster demonstrates the drug's neuroprotective potential through its activation of Nurr1, showing reduced neuronal loss and injury both directly and indirectly by decreasing microglial activation in preclinical models.
Immunic (Nasdaq: IMUX) ha presentato dati chiave sul suo principale asset vidofludimus calcio (IMU-838) al Forum ACTRIMS 2025 attraverso due presentazioni poster. La prima presentazione analizza le caratteristiche di base dei pazienti in sottogruppi del trial di fase 2 CALLIPER nella sclerosi multipla progressiva (SMP), confrontandole con quattro importanti trial sulla SMP.
L'azienda prevede di pubblicare i dati principali del trial CALLIPER ad aprile, che valuteranno gli effetti del vidofludimus calcio sul peggioramento della disabilità confermata a 24 settimane in pazienti con SMP non attiva. Il secondo poster dimostra il potenziale neuroprotettivo del farmaco attraverso l'attivazione di Nurr1, mostrando una riduzione della perdita neuronale e del danno sia direttamente che indirettamente diminuendo l'attivazione microgliale in modelli preclinici.
Immunic (Nasdaq: IMUX) presentó datos clave sobre su principal activo vidofludimus calcio (IMU-838) en el Foro ACTRIMS 2025 a través de dos presentaciones en póster. La primera presentación analiza las características basales de los pacientes en subpoblaciones del ensayo de fase 2 CALLIPER en esclerosis múltiple progresiva (EMP), comparándolas con cuatro ensayos importantes de EMP.
La empresa espera datos preliminares del ensayo CALLIPER en abril, que evaluarán los efectos del vidofludimus calcio en el empeoramiento de la discapacidad confirmada a las 24 semanas en pacientes con EMP no activa. El segundo póster demuestra el potencial neuroprotector del fármaco a través de su activación de Nurr1, mostrando una reducción de la pérdida y el daño neuronal tanto de forma directa como indirecta al disminuir la activación microglial en modelos preclínicos.
Immunic (Nasdaq: IMUX)는 ACTRIMS 포럼 2025에서 두 개의 포스터 발표를 통해 주요 자산인 비도플루디무스 칼슘 (IMU-838)에 대한 핵심 데이터를 발표했습니다. 첫 번째 발표는 진행성 다발성 경화증(PMS)의 2상 CALLIPER 시험에서 환자의 기초 특성을 분석하고 이를 네 가지 주요 PMS 시험과 비교합니다.
회사는 비도플루디무스 칼슘이 비활성 PMS 환자에서 24주 동안 확인된 장애 악화에 미치는 영향을 평가하는 CALLIPER 시험의 주요 데이터를 4월에 발표할 것으로 예상하고 있습니다. 두 번째 포스터는 약물이 Nurr1을 활성화하여 신경 보호 잠재력을 보여주며, 전임상 모델에서 미세아교세포의 활성화를 감소시켜 직접적 및 간접적으로 신경 손실과 손상을 줄이는 것을 보여줍니다.
Immunic (Nasdaq: IMUX) a présenté des données clés sur son principal actif vidofludimus calcium (IMU-838) lors du Forum ACTRIMS 2025 à travers deux présentations sous forme de posters. La première présentation analyse les caractéristiques de base des patients dans des sous-populations de l'essai de phase 2 CALLIPER dans la sclérose en plaques progressive (SPP), en les comparant à quatre grands essais sur la SPP.
L'entreprise s'attend à des données préliminaires de l'essai CALLIPER en avril, qui évalueront les effets du vidofludimus calcium sur l'aggravation de l'incapacité confirmée sur 24 semaines chez les patients atteints de SPP non active. Le deuxième poster démontre le potentiel neuroprotecteur du médicament à travers son activation de Nurr1, montrant une réduction de la perte neuronale et des lésions, tant directement qu'indirectement, en diminuant l'activation des microglies dans des modèles précliniques.
Immunic (Nasdaq: IMUX) hat auf dem ACTRIMS Forum 2025 wichtige Daten zu seinem Hauptprodukt Vidofludimus Calcium (IMU-838) in zwei Posterpräsentationen vorgestellt. Die erste Präsentation analysiert die Basismerkmale von Patienten in Subpopulationen der Phase-2-Studie CALLIPER bei fortschreitender Multipler Sklerose (PMS) und vergleicht diese mit vier großen PMS-Studien.
Das Unternehmen erwartet die Hauptdaten der CALLIPER-Studie im April, die die Auswirkungen von Vidofludimus Calcium auf die bestätigte Verschlechterung der Behinderung über 24 Wochen bei nicht aktiven PMS-Patienten bewerten werden. Das zweite Poster zeigt das neuroprotektive Potenzial des Medikaments durch die Aktivierung von Nurr1 und zeigt eine reduzierte neuronale Verlust und Verletzung sowohl direkt als auch indirekt durch die Verringerung der Mikroglialaktivierung in präklinischen Modellen.
- Phase 2 CALLIPER trial data readout expected in April 2025
- Preclinical data shows neuroprotective potential through Nurr1 activation
- Demonstrated reduction in neuronal loss and injury in preclinical models
- None.
Insights
Immunic's ACTRIMS Forum presentations highlight potentially significant developments for vidofludimus calcium, with important implications for investors ahead of April's critical Phase 2 CALLIPER data readout in progressive multiple sclerosis (PMS).
The company's analysis comparing CALLIPER patient baseline characteristics to four major PMS trials (ORATORIO, EXPAND, MS-STAT2, HERCULES) is strategically important. This comparison will allow investors to better contextualize the upcoming results against established benchmarks and potentially differentiate vidofludimus calcium's performance profile. The focus on progression independent of relapse activity (PIRA) is particularly noteworthy, as this represents one of the most challenging aspects of MS with effective treatments.
The preclinical data demonstrating neuroprotective effects through Nurr1 activation represents a differentiated mechanism in the MS treatment landscape. Most existing MS therapies primarily target inflammation, while progressive MS involves neurodegeneration that continues despite suppressed inflammation. A dual-action agent addressing both pathways could potentially capture market share in the
For investors, several considerations are critical:
- With
$108 million market cap, positive CALLIPER data could trigger significant revaluation, as successful PMS treatments command premium valuations - The April readout represents a binary event that will likely determine Immunic's near-term trajectory
- The company's focus on oral small molecules offers potential advantages over injectable/infused biologics that dominate MS treatment
- Vidofludimus calcium's potential neuroprotective properties could position it uniquely among oral MS therapies if supported by clinical data
The risk profile remains substantial given the historically high failure rate in PMS trials, though the company's mechanistic evidence provides some differentiation from previous unsuccessful approaches. Investors should monitor for signals of both disability progression (primary endpoint) and neuroprotection markers in the upcoming data.
– Vidofludimus Calcium's Activation of Nurr1 Reduces Neuronal Loss and Injury Directly and Indirectly By Decreasing Microglial Activations in Preclinical Models –
– Top-Line Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis Expected in April –
"Having two poster presentations on vidofludimus calcium at the prestigious ACTRIMS Forum highlights the unique importance of our drug candidate and its promise as a potential new treatment option for multiple sclerosis (MS)," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "For the first time, we analyzed the baseline characteristics of patients in subpopulations from our phase 2 CALLIPER trial in progressive multiple sclerosis (PMS), and compared to those from four major PMS trials. The goal of this analysis was to identify how the differences may impact comparability of trial outcomes, including our top-line data readout of the phase 2 CALLIPER trial, expected in April. The CALLIPER data is expected to provide valuable insights into the effects of vidofludimus calcium in a non-active PMS population. We believe any impact of vidofludimus calcium on 24-week confirmed disability worsening in this group would likely primarily reflect its influence on compartmentalized pathology within the central nervous system, expressed clinically as progression independent of relapse activity (PIRA)."
Presentation Details:
- Poster Title: Baseline Characteristics Across Major Clinical Trials in Progressive Multiple Sclerosis: Insights from ORATORIO, EXPAND, MS-STAT2, HERCULES, and CALLIPER
- Presenting Author: Robert J. Fox, M.D., Staff Neurologist, Mellon Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic,
Cleveland, Ohio - Abstract Number: 452
- Poster Number: P102
- Poster Session: 1
- Session Date: Thursday, February 27, 2025
- Session Time: 6:00 pm – 7:30 pm ET (even-numbered posters present from 6:00-6:45 pm)
Hella Kohlhof, PhD., Chief Scientific Officer of Immunic, continued, "Our second poster highlights, via a series of both in vitro and in vivo experiments, evidence of the neuroprotective potential of vidofludimus calcium through its activation of the transcription factor Nurr1. Overall, the data from these preclinical studies underlines that vidofludimus calcium reduces neuronal loss and injury directly and indirectly by decreasing microglial activation and that its potential neuroprotective effects are most likely mediated by Nurr1."
Presentation Details:
- Poster Title: Vidofludimus Calcium Shows a Potential Neuroprotective Function in Multiple Sclerosis through its Activity on Nurr1 in Preclinical Models
- Presenting Author: Evelyn Peelen, Ph.D., Head of Research, Immunic
- Abstract Number: 427
- Poster Number: P317
- Poster Session: 2
- Session Date: Friday, February 28, 2025
- Session Time: 6:00 pm – 7:30 pm ET (odd-numbered posters present from 6:45-7:30 pm)
Both poster presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations.
About Vidofludimus Calcium (IMU-838)
Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), which is associated with direct neuroprotective effects. Additionally, vidofludimus calcium is a highly selective inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 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 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. 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, the COVID-19 pandemic, increasing inflation, impacts of the
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com
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SOURCE Immunic, Inc.
FAQ
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