お知らせ • Sep 25
Immunic, Inc. Presents Key Vidofludimus Calcium Data At the 41st Congress of ECTRIMS, Highlighting Its Potential in Multiple Sclerosis
Immunic, Inc. announced the presentation of key data in an oral and four poster presentations, including one late-breaking poster, at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held September 24-26, 2025 in Barcelona, Spain. The data highlight Immunic's orally available lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium's (IMU-838) therapeutic potential in multiple sclerosis (MS). 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; 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 23.8% versus placebo (hazard ratio (HR) 0.762). Among patients without Gd+ lesions at baseline, vidofludimus calcium reduced the risk of 24wCDW by 33.7% overall (HR 0.663). The increase in mean EDSS in the overall PMS population was reduced statistically significant (p<0.05) at 60, 72, 84, 96 and 108 weeks with p<0.01 at 120 weeks. The time to 24wCDI for the overall PMS population demonstrated a statistically significant hazard ratio compared to placebo (n=467, HR 2.441, p=0.034). Further analyses by disease subtype showed that vidofludimus calcium was associated with 24wCDI in the PPMS study population (n=152) compared to placebo (HR 2.823), and in the naSPMS study population (n=268) compared to placebo (HR 1.813). 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; 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. At week 144 of the phase 2 EMPhASIS open-label extension (OLE) period, 92.3% of patients remained free of 12wCDW and 92.7% remained free of 24wCDW. At 12-weeks following the trigger event, up to week 144, a total of 29 CDW events were confirmed, of which 44.8% were associated with relapse-associated worsening (RAW) and only 13.8% were defined as progression independent of relapse activity (PIRA). Cumulative data from up to 5.5 years of treatment further reinforced vidofludimus calcium's favorable long-term safety and tolerability profile, with low discontinuation rates, low rates of adverse events, and no new safety signals identified. 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; 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 6.4%. The most common treatment-emergent adverse events were mild, with low rates of renal and liver-related events and no new safety signals observed. Serious adverse events were infrequent and none were deemed related to treatment. These results suggest a favorable long-term safety and tolerability profile for vidofludimus calcium in RRMS. Title:Potential Neuroprotective Activity by Vidofludimus Calcium in Vivo Models of Multiple Sclerosis; 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 (IFN?). 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.