“During the second quarter and more recently, we have made substantial clinical progress in advancing our potentially transformative lead asset, vidofludimus calcium, an orally available nuclear receptor-related 1 (Nurr1) activator,” stated Daniel Vitt, Chief Executive Officer of Immunic (IMUX). “Most notable was the on-time completion of enrollment of our twin phase 3 ENSURE trials, bringing us one step closer to delivering a novel treatment option for people living with relapsing multiple sclerosis (RMS). The unique neuroprotective effects observed to date also support the phase 3 ENSURE trials, where confirmed disability worsening will be analyzed. Top-line data from both trials, expected by the end of 2026, will allow for a synchronized readout and a pooled analysis of this clinical endpoint. The growing body of evidence we have amassed continues to strengthen our confidence that, if approved, vidofludimus calcium, with a distinct combination of neuroprotective, anti-inflammatory and anti-viral properties observed, as well as a well-established safety and tolerability profile, has the potential to emerge as a differentiated oral therapy that addresses the complex pathophysiology of multiple sclerosis.”
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