Immunic, Inc. (Nasdaq: IMUX) is advancing its clinical pipeline with vidofludimus calcium (IMU-838), an orally administered small molecule therapy, for chronic inflammatory and autoimmune diseases. The company's lead program targets multiple sclerosis (MS), with ongoing Phase 3 trials for relapsing MS and a Phase 2 trial for progressive MS.
ENSURE Program Update
The Phase 3 ENSURE program, consisting of two twin trials in relapsing multiple sclerosis (RMS), recently underwent an interim futility analysis. An unblinded Independent Data Monitoring Committee (IDMC) confirmed that the predetermined futility criteria were not met and recommended that the trials continue as planned, without any sample size increase. Immunic anticipates completing the ENSURE-1 trial in the second quarter of 2026 and the ENSURE-2 trial in the second half of 2026.
CALLIPER Trial in Progressive MS
The Phase 2 CALLIPER trial is evaluating vidofludimus calcium in patients with progressive multiple sclerosis (PMS). Top-line data from this trial is expected in April 2025. Interim data from CALLIPER supported the potential of vidofludimus calcium in slowing disease progression in PMS and substantiated its neuroprotective capabilities through the activation of Nurr1. If the top-line data confirm this neuroprotective effect and the trial meets its primary and key secondary endpoints, vidofludimus calcium could become the first oral treatment option for non-relapsing secondary progressive MS (SPMS).
ECTRIMS Presentations
Immunic presented data at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), showcasing key aspects of vidofludimus calcium's profile. This included neurofilament light chain (NfL) interim data from the Phase 2 CALLIPER trial, which showed a clear separation from placebo in NfL levels across the PMS patient population, including non-relapsing SPMS. Additional data presented included antiviral effects suggesting a reduction in fatigue, Nurr1 target data supporting neuroprotective potential, and pathogenic T cell data supporting anti-inflammatory effects.
Vidofludimus Calcium's Potential
Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). Immunic believes that, if approved, vidofludimus calcium would represent a unique new treatment option targeted to the complex pathophysiology of MS.
IMU-856 for Gastrointestinal Disorders
Immunic is also advancing IMU-856, an orally available, systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), for gastrointestinal disorders. Based on initial clinical proof-of-concept data, IMU-856 could offer a new therapeutic approach by restoring a healthy gut through renewal of the bowel wall. Phase 1b clinical trial data in patients with celiac disease showed positive effects over placebo in protection of the gut architecture, improvement of patients' symptoms, biomarker response, and enhancement of nutrient absorption. The company is preparing for Phase 2 testing of IMU-856, contingent on financing, licensing, or partnering.
Financial Update
Immunic's cash and cash equivalents as of September 30, 2024, were $59.1 million. The company expects these funds to support operations into the third quarter of 2025.
