Immunic (IMUX) Leerink Global Healthcare Conference 2026 summary

Product differentiation and mechanism of action

• Vidofludimus Calcium uniquely activates Nurr1, a nuclear receptor involved in neuroprotection, and inhibits DHODH, providing both neuroprotective and anti-inflammatory effects in multiple sclerosis (MS).

• The dual mechanism distinguishes it from other MS treatments, with Nurr1 activation translating into clinical benefit as shown in the CALLIPER data.

• Originally developed as a selective DHODH inhibitor to avoid kinase-related toxicities, its neuroprotective effects were later discovered.

Clinical trial results and efficacy

• Phase II EMPhASIS study showed a 76% reduction in cumulative active lesions and 78% reduction in gadolinium-enhancing lesions at higher doses, with robust anti-inflammatory activity.

• Dose-dependent reduction in serum neurofilament light (NFL) was observed, correlating with reduced disability progression.

• Safety and tolerability were comparable to placebo, with a highly differentiated profile versus existing therapies.

• Compared to other oral MS drugs, efficacy is on par with leading therapies, and safety profile avoids common adverse events like GI toxicity and liver issues.

Phase III program and future plans

• Two identical phase III ENSURE studies in relapsing MS, fully enrolled with 1,100 patients, focus on time to first relapse as the primary endpoint, with secondary endpoints including MRI biomarkers, NFL, and disability progression.

• Interim futility analysis indicated the studies are on track, with both expected to read out by the end of the year.

• Statistical assumptions are based on a 90% power and a hazard ratio of 0.67.