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Immunic, Inc.'s Interim Dosing Analysis of IMU-838 as Part of its Ongoing Phase 2 CALDOSE-1 Study in Patients with Moderate-to-Severe Ulcerative Colitis Establishes Broad, Potentially Safe and Effective Dose Range
SAN DIEGO, Sept. 5, 2019 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing potentially
About this update from Immunic, Inc.
[{"type":"text","content":"SAN DIEGO, Sept. 5, 2019 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing potentially best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced the results of a pre-planned interim dosing analysis in the phase 2 CALDOSE-1 study of IMU-838 in patients with moderate-to-severe ulcerative colitis (UC). Based on the available data, an unblinded and independent data review committee has concluded that the study's lowest, 10 mg dose was found not to be likely ineffective and that the highest, 45 mg dose was not intolerable. As a result, the company intends to continue the trial with all three dosing arms.\nThe phase 2 CALDOSE-1 trial is an international, multicenter, double-blind, placebo-controlled study being conducted in the United States and Europe and is designed to evaluate the company's lead compound, IMU-838, in patients with UC. The study's primary endpoint comprises a composite of a patient reported outcome and endoscopy-assessed outcome, both to be evaluated following ten weeks of induction treatment with IMU-838 or placebo.\nUnder an agreement between Immunic and the U.S. Food and Drug Administration (FDA), reached during the company's pre-IND meeting in 2017, the CALDOSE-1 trial was designed to begin enrollment with three active dosing arms of 10 mg, 30 mg and 45 mg, respectively, in addition to a placebo arm. Based on preclinical target engagement data, Immunic had hypothesized 30 mg to be the lowest effective dose. The 10 mg dose was added to the trial at the suggestion of the FDA to include a lower dose than the expected effective doses. The interim dosing analysis was to be conducted after approximately 60 patients were evaluable following their ten-week induction treatment. At the time, Immunic anticipated that the lowest, 10 mg dose might be found to be likely ineffective in this interim dosing analysis, and therefore discontinued.\nThe interim dosing analysis has now been performed by an unblinded and independent data review committee, which has concluded that the 10 mg dose appeared not to be likely ineffective, the 45 mg dose was not intolerable, and no safety signal was identified for any of the trial's three doses of IMU-838. The data review committee has not shared with the company any of the unb...