- 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
- Vidofludimus Calcium Continues to Demonstrate Favorable Safety and Tolerability Profile; Long-Term Data Now Available up to 5.5 Years
NEW YORK, NY — 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).
“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 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 emerged during treatment durations up to 5.5 years.
“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 (71.6% of patients starting OLE) were evaluated up to week 144, which translates into approximately 952 overall treatment years.
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.
Contact Information
Immunic, Inc.
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