Immunic has completed the enrolment of patients in the Phase II CALLIPER trial evaluating its lead asset, vidofludimus calcium (IMU-838), for progressive multiple sclerosis (PMS).
This international, multicentre, placebo-controlled, randomised, double-blind study is being conducted simultaneously with Immunic’s twin Phase III ENSURE trials in relapsing multiple sclerosis.
It enrolled a total of 467 patients with primary PMS, or active or non-active secondary PMS from more than 70 sites across Western, Central and Eastern Europe, and North America.
They will receive a daily dose of either 45mg vidofludimus calcium or a placebo.
The annualised rate of per cent brain volume change up to 120 weeks is the primary endpoint while the change in whole brain atrophy is the key secondary endpoint of the study.
Other key secondary endpoints include a change in time to 24-week confirmed disability progression, based on the expanded disability status scale.
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Top-line data readout of total patients from the study is anticipated in April 2025.
Immunic chief medical officer Andreas Muehler said: “As reported in May of this year, in preclinical testing, we have discovered strong neuroprotective effects as a first-in-class nuclear receptor-related 1 (Nurr1) agonism by vidofludimus calcium.
“The neuroprotective properties of vidofludimus calcium were already identified in our Phase II EMPhASIS trial of vidofludimus calcium in relapsing-remitting MS, by showing an initial signal for prevention of confirmed disability worsening, as reported in November of last year.
“We look forward to reporting the interim analysis of our CALLIPER trial, expected in the fall of this year, to assess biomarkers that have been shown in third-party research to consistently correlate with disease activity in neurodegenerative disorders.”
The interim analysis will include unblinded serum neurofilament light chain (NfL) biomarker data of 225 patients who completed a follow-up period of at least 24 weeks of treatment.