Immunic, Inc. announced the completion of enrollment of its phase 2 callIPER trial of lead asset, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS). In total, 467 patients with primary PMS, or active or non-active secondary PMS have been randomized to either 45mg of vidofludimuscium or placebo. Key secondary endpoints include the annualized rate of change in whole brain atrophy and time to 24-week confirmed disability progression based on the expanded disability status scale (EDSS).

Multiple sclerosis (MS) is an autoimmune disease that affects the brain, spinal cord and optic nerve. Vidofludimus calcium is not yet licensed or approved in any country. An interim analysis comprising unblinded biomarker data, including serum neurofilament light chain (NfL), is expected to be available in the fall of 2023 and will include data for approximately half of the enrolled patients (225) who have completed a follow-up period of at least 24 weeks of study treatment.

A top-line data readout of the full 467 patients is now expected in April of 2025.