Immunic has reported new positive data from a Phase 2 trial of vidofludimus calcium (IMU-838) to treat relapsing-remitting multiple sclerosis (RRMS). The treatment has helped reduce the rate of confirmed disability worsening over time and compares favorably to historical trial data for currently available multiple sclerosis (MS) drugs.
EMPhASIS is an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial evaluating the efficacy and safety of vidofludimus calcium in patients with RRMS.
The trial, which initially included a 24-week blinded primary treatment period evaluating vidofludimus calcium and placebo, would have met its primary and secondary endpoints in 2020.
During the 24-week core treatment period, confirmed disability worsening events over 12 and 24 weeks occurred in 1.6% of subjects in the vidofludimus calcium combination treatment arms versus 3.7% in the placebo group.
An optional long-term open-label extension (OLE) phase was also included in the trial, lasting up to 9.5 years. An interim analysis was performed with data extraction in October 2022, when 209 patients remained on treatment in the OLE phase, some having already received more than 180 continuous weeks of active treatment with vidofludimus calcium.
In the OLE phase, the proportion of patients without confirmed events of worsening disability over 12 weeks was 97.6% after 48 weeks and 94.5% after 96 weeks of treatment with vidofludimus calcium compared to the beginning of the phase. OLE.
Similar results were seen for 24-week confirmed disability worsening events and confirmed sustained disability worsening events, the company reported, with the OLE phase showing low relapse activity.
MS is a crippling and unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. The disease affects approximately 2.5 million people worldwide.
Relapsing forms of MS are characterized by clearly defined, but unpredictable, attacks of worsening neurological function, followed by periods of partial or complete recovery. About 85% of patients are initially diagnosed with relapsing forms of MS, compared to 10-15% with progressive forms of the disease.
Daniel Vitt, CEO and President of Immunic, said, “If approved, we believe that vidofludimus calcium has the potential to be a unique treatment option targeted at MS biology with anti-inflammatory effects. inflammatory, antiviral and neuroprotective agents combined.