Immunic’s vidofludimus calcium shows positive results in Phase 2 PMS trial

Immunic (IMUX) announced positive data from its phase 2 CALLIPER trial of nuclear receptor related 1, or Nurr1, activator, vidofludimus calcium, in patients with progressive multiple sclerosis, or PMS. In the overall PMS patient population, vidofludimus calcium reduced the relative risk of 24-week confirmed disability worsening events based on changes in the expanded disability status scale by 20% compared to placebo. Vidofludimus calcium was associated with a 30% reduction in the relative risk of 24wCDW events in the primary progressive multiple sclerosis study population vs. placebo and a respective 15% reduction in the non-active secondary progressive multiple sclerosis study population. Vidofludimus calcium reduced the relative risk of 24wCDW events in patients without gadolinium-enhancing lesions at baseline by 29% compared to placebo. In Immunic believes the substantial effect in these patients, therefore, underlines the previously observed neuroprotective effect of Nurr1 activation by vidofludimus calcium. Vidofludimus calcium substantially reduced the annualized rate of thalamic brain volume loss by 20% in patients with PMS compared to placebo. The top-line CALLIPER data set confirmed the favorable safety and tolerability profile of vidofludimus calcium already observed in previous clinical trials. No new safety signals were identified.