Immunic (NASDAQ: IMUX) has announced new, positive 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).
The data at week 144 showed that 92.3% of patients remained free of 12-week confirmed disability worsening (CDW) events, as measured by the Expanded Disability Status Scale (EDSS), with 92.7% remaining free of 24-week CDW.
“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 CDW events as measured by the 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,” Andreas Muehler, MD, MBA, CMO of Immunic, stated.
Daniel Vitt, Ph.D., CEO of Immunic, commented, “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. 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.”
Dr. Vitt concluded, “Additionally, previously announced data across our MS program, including from the EMPhASIS trial as well as our recent top-line data from the Phase 2 CALLIPER trial in progressive MS, 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.”
