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Immunic (IMUX) investor relations material
Immunic H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Product pipeline and clinical focus
Two clinical-stage assets: IMU-856 (SIRT6 modulator for GI diseases) and vidofludimus calcium (first-in-class oral Nurr1 activator and DHODH inhibitor for MS).
IMU-856 has proof-of-concept data in celiac disease, showing dose-dependent GLP-1 increase.
Vidofludimus calcium targets both neuroinflammation and neurodegeneration in MS via DHODH inhibition and NRR-1 activation.
Unmet need and mechanism of action in MS
Current MS therapies address only neuroinflammation, not neurodegeneration.
Vidofludimus calcium is the first to activate NRR-1, providing direct and indirect neuroprotective effects.
DHODH inhibition offers anti-inflammatory and antiviral benefits, including prevention of Epstein-Barr virus reactivation.
NRR-1 activation is linked to neuroprotection, supported by preclinical and pregnancy data.
Clinical trial results and safety profile
Phase II EMPhASIS study met primary and key secondary endpoints, showing 76% reduction in active lesions and >50% reduction in confirmed disability worsening at 24 weeks.
Phase II CALLIPER trial in progressive MS showed a 24% risk reduction in 24-week confirmed disability worsening overall, 31% in primary progressive MS, and 34% in patients without baseline inflammatory lesions.
Open-label extension shows <8% confirmed disability worsening at 144 weeks, with strong safety and tolerability.
Dose-dependent reduction in serum neurofilament light chain, a biomarker for axonal damage.
Vidofludimus calcium was well-tolerated, with adverse events similar to placebo, very low discontinuation rates (2.8%), and no increased risk of serious infections or malignancies.
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