Immunic announced that patient enrollment is now complete in its twin Phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis. A total of 1,121 patients were randomized in ENSURE-1 and 1,100 patients in ENSURE-2 across over 100 clinical sites spanning 15 countries. The synchronized top-line readout for both trials is expected by the end of 2026, marking a pivotal inflection point that will inform the company’s long-term commercial and development strategy in RMS.

Data from the Phase 2 CALLIPER trial in progressive multiple sclerosis showed that vidofludimus calcium achieved clinically meaningful reductions in 24-week confirmed disability worsening (24wCDW) across the overall PMS population and key subgroups, including primary progressive and non-active secondary progressive MS. The 24-week confirmed disability improvement (24wCDI) endpoint demonstrated more than a two-fold increase in probability of improvement versus placebo, with statistical significance in the overall PMS cohort. MRI analyses further revealed reduced thalamic atrophy and lower new or enlarging T2 lesion volume, and no new safety signals emerged, reinforcing the drug’s dual mechanism of action—direct neuroprotection via Nurr1 activation and anti-inflammatory DHODH inhibition.

Open-label extension data from the Phase 2 EMPhASIS study in relapsing-remitting MS showed that at week 144, 92.3% of patients remained free of 12-week CDW and 92.7% free of 24-week CDW, with favorable safety and tolerability observed over up to 5.5 years of follow-up. In parallel, Immunic received a Notice of Allowance from the U.S. Patent and Trademark Office for dose strengths of vidofludimus calcium in progressive MS, extending intellectual property protection in the United States into 2041 under the company’s multilayered patent strategy.

In 2025, Immunic bolstered its financial position by closing a $5.1 million registered direct offering led by Aberdeen Investments and an oversubscribed $65 million underwritten public offering co-led by BVF Partners and Coastlands Capital, with participation from Adage Capital Partners, Janus Henderson Investors and others. These financings provide runway to support the upcoming Phase 3 data readouts and advancement of the company’s next pipeline candidate, IMU-856, in gastrointestinal and weight-management indications.