Immunic has reported positive new data from a phase 2 trial of vidofludimus calcium (IMU-838) to treat relapsing-remitting multiple sclerosis (RRMS). The treatment helped to lower the rate of confirmed disability worsening over time and compared favourably to historical trial data for currently available multiple sclerosis (MS) medications.
EMPhASIS is an international, multicentre, double-blind, placebo-controlled, randomised, parallel-group trial, assessing the efficacy and safety of vidofludimus calcium in patients with RRMS.
The trial, which initially included a 24-week blinded main treatment period evaluating vidofludimus calcium and placebo, was reported to have met both its primary and key secondary endpoints in 2020.
During the main 24-week treatment period, 12-week and 24-week confirmed disability worsening events occurred in 1.6% of subjects in the combined vidofludimus calcium treatment arms compared with 3.7% in the placebo group.
An optional long-term open-label extension (OLE) phase was also included in the trial, running 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, with some having already received over 180 continuous weeks of active treatment with vidofludimus calcium.
In the OLE phase, the proportion of patients free from 12-week confirmed disability worsening events was 97.6% after 48 weeks and 94.5% after 96 weeks of vidofludimus calcium treatment compared to the start of the OLE phase.
Similar results were observed for 24-week confirmed disability worsening events and sustained confirmed disability worsening events, the company reported, with the OLE phase showing low relapse activity.
MS is a disabling, 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 characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared with 10-15% with progressive forms of the disease.
Daniel Vitt, chief executive officer and president of Immunic said: “If approved, we believe that vidofludimus calcium has the potential to be a unique treatment option targeted to the biology of MS with combined anti-inflammatory, antiviral, and neuroprotective effects.”