Immunic misses Phase II endpoint of MS trial

Immunic's vidofludimus calcium (IMU-838) missed the primary MRI endpoint in its Phase II CALLIPER study for primary progressive multiple sclerosis (PMS), showing only a 5% annualized rate of brain volume change compared to placebo. However, the drug demonstrated a 20% reduction in thalamic brain volume loss and a 20% reduction in the risk of disability worsening (24-week confirmed disability worsening or 24wCDW) in patients with PMS. The subgroup analysis showed an even higher benefit, with a 30% reduction in 24wCDW events for the primary progressive MS population.

The drug was well-tolerated, with no new safety signals. The study continues, evaluating the efficacy and safety of the Nurr1 activator in 467 patients, with an open-label extension phase lasting up to eight years. Immunic is advancing two Phase III trials in relapsing MS, expected to complete by 2026.

04-05-2025