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Immunic, Inc. Enrolls First Patient in Its Phase 2 CALLIPER Trial of IMU-838 in Progressive Multiple Sclerosis
NEW YORK, Sept. 30, 2021 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral
About this update from Immunic, Inc.
[{"type":"text","content":"NEW YORK, Sept. 30, 2021 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced enrollment of the first patient in its phase 2 CALLIPER trial of lead asset IMU-838, the company's selective oral DHODH inhibitor, in patients with progressive multiple sclerosis (PMS). The trial, which is intended to run concurrently with and as a complement to the company's twin phase 3 ENSURE trials in relapsing-remitting multiple sclerosis (RRMS), is focused on progressive forms of multiple sclerosis (MS) and designed to corroborate IMU-838's neuroprotective potential in this patient population.\nCALLIPER 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.\n\"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.\"\n\"The CALLIPER trial is designed ...