Immunic (IMUX) R&D Day 2026 summary

Pipeline overview and program updates

• Vidofludimus calcium combines direct Nurr1 activation, intended to support neuronal resilience, with selective DHODH inhibition targeting activated immune cells.

• ProTEct-MS is planned as a Phase III, placebo-controlled study of ~1,400 patients with PPMS or non-active SPMS; first enrollment is expected in H1 2027.

• ENSURE-1 and ENSURE-2 are fully enrolled, with top-line relapsing-MS data expected in December 2026; a mid-2027 NDA submission and 2028 U.S. approval/launch are conditional on results.

• IMU-381 remains in candidate screening.

Clinical trial data and development milestones

• CALLIPER randomized 467 patients; its primary brain-volume endpoint was not significant at month 30 (4.7% relative difference; 95% CI -0.285 to 0.379; P=0.78).

• Through week 120, 24-week confirmed disability improvement was nominally significant (P=0.034) and confirmed disability-worsening trends favored treatment; the study was not powered to establish disability benefit.

• Exploratory MRI results included fewer slowly expanding lesions at week 96 (2.935 vs. 3.840; nominal P<0.05) and nominally lower new/enlarging T2 lesion volume at weeks 48, 72 and 96.

• More than 340 CALLIPER participants continued into the open-label extension; CDI was nominally significant (P=0.0075), and the disability win ratio favored treatment at 1.51 (nominal P=0.042).

• ProTEct-MS primary endpoint is time to 24-week confirmed disability worsening or 9-Hole Peg Test worsening; secondary measures include improvement, imaging, mobility, cognition and patient-reported outcomes.

R&D strategy and innovation priorities

• MS was presented as a spectrum in which relapsing and progressive biology can coexist early; 80%–90% of disability-worsening events in cited relapsing trials were attributed to PIRA.

• Development strategy emphasizes mechanism-based enrollment, pooled progressive phenotypes and evaluating disease biology beyond traditional clinical labels.

• Experts advocated multimodal endpoints combining clinical measures with imaging and blood biomarkers; PRLs, slowly expanding lesions, NfL and GFAP may help enrich trials or assess response.

• Preclinical work linked Nurr1 activation to neuronal survival and reduced inflammatory glial signaling; Nurr1 knockdown removed the observed survival benefit in cell models.