Vidofludimus Calcium (IMU-838) - (CALLIPER)

October 7, 2026: Immunic, Inc. (NASDAQ: IMUX) said four abstracts on investigational vidofludimus calcium (IMU-838) were accepted for presentation at MSToronto2026 (10th Joint ACTRIMS-ECTRIMS Meeting, October 21-23, 2026) in multiple sclerosis.

CALLIPER Phase 2/OLE, progressive MS: new open-label extension analyses showed disability outcomes favored continuous vidofludimus calcium versus patients who switched from placebo at OLE entry. A high proportion entered the extension, discontinuation remained low, trends toward lower risk of 24-week confirmed disability worsening were maintained, and confirmed disability improvement occurred more frequently. Another CALLIPER analysis reported statistically significant results for a proposed confirmed disability change endpoint integrating worsening and improvement, with similar findings using generalized pairwise comparisons.

Biomarker/Cognition, progressive MS: a post-hoc CALLIPER analysis found vidofludimus calcium significantly reduced EBV-specific T-cell receptor signatures versus placebo, while influenza A-specific signatures were unchanged. Across both arms, reductions in EBV-specific signatures were associated with improved Symbol Digit Modalities Test performance, mainly in primary progressive MS participants.

Preclinical: vidofludimus calcium promoted neuronal survival in human neuronal cells under apoptotic stress, lost with Nurr1 knockout, attenuated microglia-driven neuronal loss, and in EAE models reduced disease severity, increased Nurr1-regulated gene expression, and lowered plasma neurofilament light chain.

Upcoming catalysts: top-line Phase 3 data in relapsing MS are expected by end of 2026; initiation of an additional Phase 3 trial in progressive MS is expected later in 2026.