Immunic Inc (NASDAQ:IMUX) said on Thursday it has fully enrolled its twin Phase 3 ENSURE trials for vidofludimus calcium, positioning the company for a major data readout by end-2026 in relapsing multiple sclerosis (RMS).
The oral therapy, which activates the Nurr1 nuclear receptor, has shown neuroprotective, anti-inflammatory, and anti-viral properties.
CEO Daniel Vitt said the trials mark a critical step toward delivering a novel MS treatment with a well-established safety and tolerability profile.
“The growing body of evidence we have amassed continues to strengthen our confidence that, if approved, vidofludimus calcium…has the potential to emerge as a differentiated oral therapy that addresses the complex pathophysiology of multiple sclerosis (MS),” Vitt told shareholders.
The company also highlighted positive Phase 2 results in progressive MS (PMS) from its CALLIPER trial, with a 23.8% reduction in time to 24-week confirmed disability worsening (24wCDW) versus placebo. In primary progressive MS (PPMS), the effect was even stronger at 31.3%, supporting the drug’s potential in a market with limited treatment options.
Long-term extension data from the EMPhASIS trial in relapsing-remitting MS reinforced prior findings, with more than 92% of patients remaining free of confirmed disability worsening after 144 weeks.
Beyond MS, Immunic is advancing IMU-856, a small molecule targeting SIRT6, for gastrointestinal disorders and weight management, with further trials under consideration pending financing or partnership. Post hoc analysis from a Phase 1b study showed a 250% increase in GLP-1 levels, suggesting potential as a once-daily oral alternative to injectable weight loss drugs.
The company raised over $70 million in the quarter and may access an additional $130 million through warrant exercises.
Immunic reported a net loss of $27 million for the quarter, up from $21.4 million a year earlier, reflecting higher R&D spending. It ended the quarter with $55.3 million in cash.