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Immunic Announces Start of Patient Cohorts in Its Phase 1 Clinical Trial of IMU-856 in Celiac Disease
– First Time Patients Will be Treated with the Company's Orally Available Small Molecule Modulator Targeting Restoration of Intestinal Barrier Function and
About this update from Immunic, Inc.
[{"type":"text","content":"– First Time Patients Will be Treated with the Company's Orally Available Small Molecule Modulator Targeting Restoration of Intestinal Barrier Function and Regeneration of Bowel Epithelium –\nNEW YORK, May 5, 2022 /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 the start of the patient cohorts in its ongoing phase 1 clinical trial of IMU-856, the company's third clinical asset, in patients with celiac disease.\nIMU-856 is an orally available and systemically acting small molecule modulator that targets an undisclosed epigenetic regulator. Preclinical studies suggest that IMU-856 can restore barrier function in the gastrointestinal tract and also regenerate intestinal architecture while maintaining immunocompetency. Based on preclinical and early clinical data available to date, the company believes that IMU-856 may represent a novel and potentially ground-breaking approach to the treatment of gastrointestinal diseases.\n\"Start of Part C of this phase 1 clinical trial in celiac disease patients marks an important milestone in the clinical development of IMU-856, and we hope to be able to confirm its ability to restore intestinal barrier function without affecting the immune system,\" stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. \"Because it represents a significant unmet need with well characterized surrogate markers of disease activity, we believe that celiac disease is an ideal initial clinical indication to provide proof-of-concept of IMU-856's acute and chronic impact. IMU-856's mechanism could present an entirely new approach to treat a significant number of serious and widely prevalent gastrointestinal diseases, and we believe it could offer a clinical benefit without the serious consequences associated with many autoimmune therapies. Moreover, we look forward to providing the full safety data set from the single and multiple ascending dose portions of this ongoing phase 1 clinical trial in healthy human subjects, currently expected to be available in the third quarter of this year.\"\n\"Celiac disease is a life-long and serious autoimmune disease of the small bowel whose pathophysiology is due to gluten-induce...