Immunic Highlights Extended Data from EMPhASIS Trial in Peer-Reviewed Journal

Immunic AG has published comprehensive findings from the phase 2 EMPhASIS trial of vidofludimus calcium for treating relapsing-remitting multiple sclerosis (RRMS) in the esteemed journal, Neurology® Neuroimmunology & Neuroinflammation. The data reveal significant efficacy of 30 mg and 45 mg daily doses in reducing MRI-detected brain lesions compared to placebo.

The recently released results also align with Interim phase 2 CALLIPER data in progressive MS, showing potential benefits beyond the initial trial parameters. Immunic's ongoing phase 3 ENSURE trials in relapsing MS and phase 2 CALLIPER trial in progressive MS are part of the company's continued exploration of vidofludimus calcium's therapeutic effects.

The published paper, authored by Dr. Robert J. Fox, displays a robust suppression of gadolinium-enhancing lesions and new combined unique active MRI lesions over 24 weeks by 78% and 74% respectively with the two evaluated doses. It further corroborates vidofludimus calcium’s dual neuroprotective and anti-inflammatory properties. The study also reported a dose-dependent decrease in serum neurofilament light chain, a marker of neuronal damage, enhancing the clinical relevance of this treatment.

In addition to efficacy, the safety profile was comparable to placebo, reinforcing the tolerability observed in over 1,800 trial participants. The new findings ensure a sustained effort in understanding and potentially expanding the therapeutic reach of vidofludimus calcium in MS and potentially other neuro-inflammatory disorders.