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Immunic, Inc. Announces Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function
NEW YORK, Aug. 20, 2020 /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, Aug. 20, 2020 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced dosing of the first healthy volunteer in the company's phase 1 clinical program of IMU-856, an orally available, small molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and paradigm-shifting approach to the treatment of gastrointestinal diseases by potentially restoring intestinal barrier function while maintaining immunocompetency. Immunic's Australian subsidiary, Immunic Australia Pty Ltd., received clearance from the Bellberry Human Research Ethics Committee in Australia to begin a phase 1 trial of IMU-856 under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutic Goods Administration (TGA). The phase 1 clinical program includes single and multiple ascending dose parts in healthy volunteers. Subsequently, Immunic also plans to extend this program to assess biomarker, safety and drug trough levels in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), ulcerative colitis (UC) and Crohn's disease (CD).\n\"Dosing of the first healthy volunteer in our phase 1 clinical program of IMU-856 brings us one step closer to evaluating whether our approach may eventually translate into a novel treatment option for patients suffering from a range of gastrointestinal diseases, by potentially restoring function of the intestinal barrier without impairing the immune system,\" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. \"Based on strong preclinical data, IMU-856 shows significant therapeutic potential for diseases that are known to be triggered by the disruption of intestinal barrier function.\"\nThe phase 1 study is a double-blind, randomized, placebo-controlled trial comprised of three parts. The first part is a single ascending dose portion in healthy volunteers, which is planned to be followed by a second, multiple ascending dose part in healthy volunteers, with IMU-856 given daily for 14 consecutive days. These first two parts of the phase 1 trial are designed to assess...