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Immunic, Inc. Announces Completion of Enrollment of its Phase 2 CALDOSE-1 Trial of IMU-838 in Moderate-to-Severe Ulcerative Colitis
- Top-Line Data Expected in the Second Quarter of 2022 - NEW YORK, Oct. 28, 2021 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage
About this update from Immunic, Inc.
[{"type":"text","content":"- Top-Line Data Expected in the Second Quarter of 2022 -\n\n\nNEW YORK, Oct. 28, 2021 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced that the final patient has been enrolled and randomized in its phase 2 CALDOSE-1 trial of lead asset, IMU-838, the company's selective oral DHODH inhibitor, in patients with moderate-to-severe ulcerative colitis (UC). Top-line data for the induction phase is expected to be available in the second quarter of 2022.\n\"Enrollment of the last patient in our CALDOSE-1 trial brings us one step further in the clinical development of IMU-838 as a potential treatment for UC patients,\" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. \"Backed by promising results from the phase 2a ENTRANCE trial performed in UC and Crohn's disease and the interim analysis of the CALDOSE-1 trial published in September 2019, along with IMU-838's already established, strong safety and tolerability profile, we believe that the drug could become a preferred oral treatment option for patients suffering from UC and looking for a convenient treatment option before being escalated to biologics. We look forward to obtaining the unblinded top-line data in the second quarter of next year.\"\nThe phase 2 CALDOSE-1 trial is a multicenter, randomized, double-blind, placebo-controlled, dose-finding study being conducted at more than 100 sites in 19 countries, including the United States and Western, Central and Eastern Europe. It is designed to evaluate the efficacy and safety of IMU-838 in patients with UC and includes a blinded induction and maintenance phase, with an option for open-label treatment extension. At the completion of patient recruitment, the trial has randomized a total of 263 patients into four arms: three active dosing arms of 10 mg, 30 mg and 45 mg, as well as placebo. The trial's primary endpoint comprises a composite of a patient-reported outcome and endoscopy-assessed outcome, both evaluated following ten weeks of induction treatment with IMU-838 or placebo. The assessment of endoscopy results is performed by an independent, central reader. \nIn September 2019, Immunic reported positive results from an interim dosing...