First Participant Treated With Vidofludimus in Phase 2 Trial
A phase 2 trial for vidofludimus calcium (VFC)(IMU-838; Immunic, New York, NY) has been initiated with the first participant treated for progressive multiple sclerosis (PMS). The CALLIPER trial (NCT05054140), which coincides with the phase 3 ENSURE trials (NCT03846219) in relapsing-remitting multiple sclerosis (RRMS), is focused on progressive forms of multiple sclerosis (MS) and designed to validate the neuroprotective potential of VFC in this patient population.
“Enrollment of the first PMS patient in our phase 2 CALLIPER trial, on schedule, is another important clinical milestone for our lead asset, IMU-838, and we continue to anticipate initiating our phase 3 ENSURE program in RRMS patients in the fourth quarter of this year,” stated Daniel Vitt, PhD, chief executive officer and president of Immunic. “We believe that if the CALLIPER trial is successful in showing a beneficial neuroprotective effect of IMU-838, this data, along with that of the ENSURE program and IMU-838’s already proven, strong safety and tolerability profile, may allow us to draw a clear clinical differentiation for IMU-838 vs other oral MS medications, resulting in an attractive commercial positioning as a transformative therapeutic treatment.”
In the earlier phase 2 EMPhASIS trial, individuals with relapsing MS (n=138) were randomly assigned 1:1 to received 45 mg/day of VFC vs placebo. VFC 30 or 45 mg/day resulted in statistically significant relative reductions of 70% (P<.0001) and 62% (P=.0002), respectively, in cumulative combined unique active (CUA) lesions on MRI over 24 weeks compared with placebo.
The CALLIPER trial is an international multicenter randomized double-blind placebo-controlled phase 2 trial expected to enroll approximately 450 participants randomized to either 45 mg daily doses of IMU-838 or placebo. The trial aims to change the annualized rate of percent brain volume up to 120 weeks. 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).