Immunic Reports New, Positive Long-Term Open-Label Extension Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis

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[{"type":"text","content":"– At Week 144, 92.3% of Patients Remained Free of 12-Week Confirmed Disability Worsening (CDW) With 92.7% Remaining Free of 24-Week CDW –","length":137,"tagName":"p","attribs":{}},{"type":"text","content":"– Vidofludimus Calcium Continues to Demonstrate Favorable Safety and Tolerability Profile; Long-Term Data Now Available up to 5.5 Years –","length":137,"tagName":"p","attribs":{}},{"type":"text","content":"NEW YORK, June 24, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today reported new long-term open-label extension (OLE) data from its phase 2 EMPhASIS trial of lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS).","length":510,"tagName":"p"},{"type":"text","content":""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.","length":644,"tagName":"p"},{"type":"text","content":"The data at week 144 showed that 92.3% of patients remained free of 12-week CDW, and 92.7% free of 24-week CDW. A total of 29 CDW events were confirmed at 12 weeks following the trigger event through week 144. Of these, 44.8% were associated with relapse-associated worsening (RAW), while only 13.8% were associated with progression independent of relapse activity (PIRA). Additionally, the cumulative data available from the EMPhASIS OLE period, thus far, further reinforces the favorable safety and tolerability profile of vidofludimus calcium, showing low discontinuation rates and low rates of treatment-emergent and serious adverse events. Importantly, no new safety signals have em...

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