Immunic Reports New, Positive Long-Term Open-Label Extension Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis
Immunic (NASDAQ:IMUX) has reported promising long-term data from the Phase 2 EMPhASIS trial's open-label extension (OLE) studying vidofludimus calcium in relapsing-remitting multiple sclerosis (RRMS) patients. At Week 144, the trial demonstrated remarkable results with 92.3% of patients remaining free of 12-week confirmed disability worsening (CDW) and 92.7% free of 24-week CDW.
The study, representing approximately 952 treatment years, showed that of 29 CDW events confirmed at 12 weeks, 44.8% were associated with relapse-associated worsening, while only 13.8% were linked to progression independent of relapse activity. The drug maintained a favorable safety profile with low discontinuation rates and no new safety signals emerging during treatment durations up to 5.5 years.
Immunic (NASDAQ:IMUX) ha riportato dati promettenti a lungo termine dall'estensione in aperto (OLE) dello studio di Fase 2 EMPhASIS, che ha valutato il vidofludimus calcium in pazienti con sclerosi multipla recidivante-remittente (RRMS). Alla Settimana 144, lo studio ha mostrato risultati notevoli con il 92,3% dei pazienti liberi da peggioramento della disabilità confermato a 12 settimane (CDW) e il 92,7% liberi da CDW a 24 settimane.
Lo studio, che rappresenta circa 952 anni di trattamento, ha evidenziato che, su 29 eventi di CDW confermati a 12 settimane, il 44,8% era associato a un peggioramento legato a recidive, mentre solo il 13,8% era correlato a una progressione indipendente dall'attività di recidiva. Il farmaco ha mantenuto un profilo di sicurezza favorevole con bassi tassi di interruzione e nessun nuovo segnale di sicurezza emerso durante trattamenti fino a 5,5 anni.
Immunic (NASDAQ:IMUX) ha informado datos prometedores a largo plazo de la extensión de etiqueta abierta (OLE) del ensayo de Fase 2 EMPhASIS, que estudia vidofludimus calcium en pacientes con esclerosis múltiple remitente-recurrente (RRMS). En la Semana 144, el ensayo mostró resultados notables con un 92.3% de pacientes libres de empeoramiento confirmado de discapacidad a 12 semanas (CDW) y un 92.7% libres de CDW a 24 semanas.
El estudio, que representa aproximadamente 952 años de tratamiento, mostró que de 29 eventos de CDW confirmados a 12 semanas, el 44.8% se asociaron con empeoramiento relacionado con recaídas, mientras que solo el 13.8% se vinculó a progresión independiente de la actividad de recaída. El medicamento mantuvo un perfil de seguridad favorable con bajas tasas de interrupción y sin nuevas señales de seguridad durante tratamientos de hasta 5.5 años.
Immunic (NASDAQ:IMUX)는 재발 완화형 다발성 경화증(RRMS) 환자를 대상으로 한 2상 EMPhASIS 시험의 공개 라벨 연장 연구(OLE)에서 비도플루디무스 칼슘의 장기 유망 데이터를 보고했습니다. 144주차에 이 시험은 92.3%의 환자가 12주 확정 장애 악화(CDW) 없이, 92.7%가 24주 CDW 없이 유지되는 탁월한 결과를 보였습니다.
약 952년 치료 기간에 해당하는 이 연구에서 12주 확정 CDW 이벤트 29건 중 44.8%는 재발 관련 악화와 연관되었으며, 13.8%만이 재발 활동과 무관한 진행과 관련이 있었습니다. 약물은 최대 5.5년까지의 치료 기간 동안 낮은 중단율과 새로운 안전성 신호 없이 우수한 안전성 프로파일을 유지했습니다.
Immunic (NASDAQ:IMUX) a rapporté des données à long terme prometteuses issues de l'extension en ouvert (OLE) de l'essai de phase 2 EMPhASIS, étudiant le vidofludimus calcium chez des patients atteints de sclérose en plaques récurrente-rémittente (RRMS). À la semaine 144, l'essai a démontré des résultats remarquables avec 92,3% des patients restants exempts d'aggravation confirmée du handicap à 12 semaines (CDW) et 92,7% exempts de CDW à 24 semaines.
L'étude, représentant environ 952 années de traitement, a montré que sur 29 événements de CDW confirmés à 12 semaines, 44,8% étaient associés à une aggravation liée à une rechute, tandis que seulement 13,8% étaient liés à une progression indépendante de l'activité de rechute. Le médicament a maintenu un profil de sécurité favorable avec un faible taux d'arrêt et aucun nouveau signal de sécurité détecté pendant des traitements allant jusqu'à 5,5 ans.
Immunic (NASDAQ:IMUX) hat vielversprechende Langzeitdaten aus der offenen Verlängerung (OLE) der Phase-2-EMPhASIS-Studie berichtet, die Vidofludimuscalcium bei Patienten mit schubförmig-remittierender Multipler Sklerose (RRMS) untersucht. Nach Woche 144 zeigte die Studie bemerkenswerte Ergebnisse, wobei 92,3% der Patienten frei von einer 12-wöchigen bestätigten Verschlechterung der Behinderung (CDW) und 92,7% frei von einer 24-wöchigen CDW blieben.
Die Studie, die etwa 952 Behandlungsjahre umfasst, zeigte, dass von 29 CDW-Ereignissen, die nach 12 Wochen bestätigt wurden, 44,8% mit einem schubbedingten Verschlechterungsereignis assoziiert waren, während nur 13,8% mit einer progredienten Verschlechterung unabhängig von Schüben in Verbindung standen. Das Medikament behielt ein günstiges Sicherheitsprofil mit niedrigen Abbruchraten und ohne neue Sicherheitssignale während Behandlungszeiten von bis zu 5,5 Jahren bei.
- 92.3% of patients remained free of 12-week CDW and 92.7% free of 24-week CDW at Week 144
- Favorable safety profile maintained for up to 5.5 years with no new safety signals
- Low discontinuation rates and low treatment-emergent adverse events
- High retention rate with 71.6% of patients continuing treatment at Week 144
- Combined neuroprotective, anti-inflammatory and anti-viral effects demonstrated
- 44.8% of CDW events were associated with relapse-associated worsening
- 29 confirmed disability worsening events occurred through week 144
Insights
Immunic's MS drug shows impressive 92% disability progression-free rate at 144 weeks with excellent long-term safety profile.
The long-term extension data from Immunic's Phase 2 EMPhASIS trial reveals remarkably strong efficacy signals for vidofludimus calcium in RRMS patients. After 144 weeks of treatment,
What's particularly notable is the drug's safety profile over extended periods - with data now available up to 5.5 years showing no new safety signals. The retention rate is impressive, with
The mechanistic details are enlightening - of the 29 CDW events confirmed at 12 weeks, only
As a Nurr1 activator with neuroprotective properties, vidofludimus calcium represents a novel therapeutic approach that could address the significant unmet need in slowing disease progression - something that remains challenging despite 30 years of MS therapies. The oral administration route provides a meaningful advantage over injectable therapies for patient compliance and quality of life considerations.
– At Week 144,
– Vidofludimus Calcium Continues to Demonstrate Favorable Safety and Tolerability Profile; Long-Term Data Now Available up to 5.5 Years –
"It is meaningful to see that patients treated with vidofludimus calcium during the OLE period of our phase 2 EMPhASIS trial in RRMS experienced a low rate of confirmed disability worsening (CDW) events, as measured by the Expanded Disability Status Scale (EDSS). This data, representing approximately 952 treatment years, further underlines our belief that vidofludimus calcium holds great potential to effectively manage the disease, help preserve neurological function, allow patients to maintain independence and improve long-term quality of life," stated Andreas Muehler, M.D., M.B.A., Chief Medical Officer of Immunic.
The data at week 144 showed that
"This new data from the OLE period is very encouraging and continues to corroborate the prior strong results we observed in our phase 2 EMPhASIS trial in RRMS," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "The ability to maintain remarkably low rates of disability progression is among the most important unmet needs in relapsing MS despite the availability of multiple anti-inflammatory drugs approved for the treatment of MS relapses. By delaying disease progression, MS patients maintain greater independence, face a lower burden in managing their symptoms and experience more favorable long-term outcomes."
"Additionally, previously announced data across our multiple sclerosis (MS) program, including from the EMPhASIS trial as well as our recent top-line data from the phase 2 CALLIPER trial in progressive multiple sclerosis, has further highlighted vidofludimus calcium's potential to slow disease progression in MS and substantiated its neuroprotective capabilities through the activation of the Nurr1 target. As a reminder, despite 30-years of commercially available MS treatments, slowing and preventing disease progression still remains a critical unmet need. Based on the data we have generated, to date, we continue to believe that vidofludimus calcium, with its combined neuroprotective, anti-inflammatory and anti-viral effects as well as its established, highly favorable safety and tolerability profile, could represent a unique new oral therapy targeted to the complex pathophysiology of MS."
The phase 2 EMPhASIS trial was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group study, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS. The trial randomized 268 RRMS patients and included a 24-week blinded main treatment period testing 10, 30 and 45 mg of vidofludimus calcium and placebo. The trial achieved both primary and key secondary endpoints with high statistical significance and showed a favorable safety and tolerability profile similar to placebo. The trial includes an optional OLE period for up to 9.5 years to evaluate long-term safety and tolerability of vidofludimus calcium. Of the 268 patients that started the double-blind main treatment period, 254 patients continued in the OLE period. Patients were initially given either 30 mg or 45 mg of vidofludimus calcium once-daily, following which all patients received 30 mg of vidofludimus calcium once-daily. At the time of data cutoff on January 14, 2025, 182 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 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
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
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ckasunich@kcsa.com
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