DGAP-News: Immunic, Inc.
/ Key word(s): Study
Immunic, Inc. Enrolls First Patient in Its Phase 2 CALLIPER Trial of IMU-838 in Progressive Multiple Sclerosis CALLIPER is an international, multicenter, randomized, double-blind, placebo-controlled phase 2 trial expected to enroll approximately 450 patients at more than 70 sites in North America, Western, Central and Eastern Europe, with patients randomized to either 45 mg daily doses of IMU-838 or placebo. The trial's primary endpoint is the annualized rate of percent brain volume change up to 120 weeks. 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). An interim analysis comprising an unblinded analysis of serum neurofilament light chain (NfL) is planned to occur once approximately half of the enrolled patients have completed 24 weeks of treatment. "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, Ph.D., 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 versus other oral MS medications, resulting in an attractive commercial positioning as a transformative therapeutic treatment." "The CALLIPER trial is designed to further explore IMU-838's neuroprotective potential, as exemplified by a slowing of brain atrophy and delay in disability worsening, which is often caused by axonal and neural damage," added Andreas Muehler, M.D., Chief Medical Officer of Immunic. "The interim analysis to assess NfL is key, as it has been shown to consistently correlate with disease activity in neurological disorders and has become one of the most important serum biomarkers for axonal damage over the past few years. If the CALLIPER trial is successful in showing beneficial data, we believe this could be an essential differentiator for IMU-838 in the MS market." For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT05054140. About Progressive Multiple Sclerosis About IMU-838 About Immunic, Inc.
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1237147 30.09.2021