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

Published: 2025-06-24 07:35:39 ET IMUX

Published on 06/24/2025 at 07:35

Immunic, Inc. 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). 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.

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.