Immunic Inc (NASDAQ:IMUX) said on Wednesday it is entering a pivotal phase for its lead multiple sclerosis drug as the biotech company prepares for key clinical readouts that could shape its longer-term growth strategy.
The Nasdaq-listed company said it has completed patient enrollment in two late-stage Phase 3 trials of vidofludimus calcium, an oral therapy being tested in relapsing multiple sclerosis (RMS), and expects synchronized top-line results by the end of 2026.
CEO Daniel Vitt said the twin ENSURE-1 and ENSURE-2 trials, which together enrolled more than 2,200 patients across 15 countries, were designed to provide a comprehensive assessment of the drug’s potential in RMS.
“We now eagerly anticipate the synchronized top-line data readout by the end of 2026,” Vitt said, adding that the scale and geographic reach of the trials could help clarify whether vidofludimus calcium can meaningfully alter the treatment landscape.
Immunic is positioning vidofludimus calcium as a differentiated oral therapy that combines anti-inflammatory effects with potential neuroprotective benefits. Current oral MS drugs largely focus on reducing relapses, but often fall short of addressing the neurodegeneration that drives long-term disability, the company said.
COO Jason Tardio said the company believes the drug’s dual mechanism, selective inhibition of DHODH alongside activation of the Nurr1 pathway, could support both neuronal protection and reduced inflammatory damage, potentially improving the overall benefit-risk profile.
Beyond relapsing forms of the disease, Immunic highlighted encouraging Phase 2 data from its CALLIPER trial in progressive multiple sclerosis (PMS), an area with fewer effective treatment options. The company said the study showed reductions in confirmed disability worsening over 24 weeks across patient subgroups, including those without signs of active inflammation at baseline.
Vitt said those findings support the hypothesis that vidofludimus calcium may exert neuroprotective effects independent of its anti-inflammatory action, which could help de-risk a future late-stage development programme in PMS.
Longer-term data from an open-label extension of the Phase 2 EMPhASIS trial in relapsing-remitting MS also showed most patients remained free of confirmed disability worsening over extended follow-up, Immunic said, reinforcing confidence ahead of the Phase 3 readout.
Alongside its MS franchise, Immunic is advancing IMU-856, an oral small-molecule targeting SIRT6 that is being explored initially for gastrointestinal diseases. Early clinical signals in celiac disease, including effects on intestinal barrier function, have prompted the company to consider broader applications, including potential use in weight management.
Immunic said it is preparing for further clinical testing of IMU-856, subject to financing or partnering, as it balances pipeline expansion with the capital demands of late-stage development.
In 2025, the company strengthened its balance sheet through a series of equity financings, including a $65 million oversubscribed public offering backed by institutional investors, as it looks ahead to data-driven milestones over the next two years.