Vidofludimus calcium linked to neurofilament light chain reduction in MS

Key takeaways:

• EMPHASIS study included 258 persons with MS given vidofludimus calcium or placebo for 24 weeks.
• Results show vidofludimus calcium may be biologically relevant beyond focal anti-inflammatory properties.

For those with relapsing-remitting multiple sclerosis, treatment with vidofludimus calcium led to reductions in neurofilament light chain biomarkers as early as week 6 compared with placebo, according to a presentation at ECTRIMS 2023.

“The poster presents a new analysis of neurofilament light chain data of our Phase 2 EMPHASIS trial of vidofludimus calcium in relapsing-remitting multiple sclerosis in light of the drug’s recently found supplemental mechanism of Nurr1 activation, a known neuroprotective target,” Andreas Muehler, MD, chief medical officer of Immunic Therapeutics, told Healio in an email.

Muehler and colleagues sought to expand analysis of the EMPHASIS clinical trial, a double-blind phase 2 study of vidofludimus calcium (VidoCa) in relapsing-remitting MS, in which the treatment showed a safety and tolerability profile and a robust benefit on MRI activity compared with placebo. They sought to evaluate dose-dependent efficacy along with safety and tolerability of the novel therapeutic compared with placebo.

They included 268 participants with RRMS and both active and inactive disease-related inflammation, given either 10 mg, 30 mg, or 45 mg of VidoCa or placebo for a double-blind treatment period of 24 weeks, during which the biomarker neurofilament light chain (Nfl) was measured.

According to results, treatment with VidoCa was associated with an Nfl reduction from baseline up to week 6 of -3% for the pooled 30 mg and 45 mg VidoCa group, compared with +2.5% for placebo, and up to week 24 of -19% and +7%, respectively.

The researchers additionally found an observed reduction from baseline to week 6 of -3% and -9% for the VidoCa groups and placebo, and up to week 24 was -18% and -13.5%, respectively, for the activity-free population. Data further showed a -18% reduction when comparing week 6 to week 24 for VidoCa and -1% for the placebo group, and of -16% and -1%, in the activity-free population, respectively.

“The persisting difference, very similar to the overall study population, in serum neurofilament light chain for vidofludimus calcium compared to placebo among patients with non-active inflammation suggests that vidofludimus calcium may have a biologically relevant effect beyond its known focal anti-inflammatory properties,” Muehler told Healio.