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Immunic Announces Publication of Data From Phase 1/1b Clinical Trial of IMU-856 in the Peer Reviewed Journal, The Lancet Gastroenterology & Hepatology
– Includes Phase 1 Data in Healthy Human Subjects and Phase 1b Data in Celiac Disease Patients – NEW YORK, Nov. 13, 2024 /PRNewswire/ -- Immunic, Inc.
About this update from Immunic, Inc.
[{"type":"text","content":"– Includes Phase 1 Data in Healthy Human Subjects and Phase 1b Data in Celiac Disease Patients –\nNEW YORK, Nov. 13, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that the data from its phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), has been published in the peer reviewed journal, The Lancet Gastroenterology & Hepatology. Lead authored by Dr. A. James Daveson, Gastroenterologist, Wesley Research Institute and Coral Sea Clinical Research Institute, Queensland, Australia, the paper is entitled, \"Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial.\" It can be accessed through the following link: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(24)00248-6/fulltext.\nDr. Daveson stated, \"Celiac disease affects approximately 1.4% of the world's population. The only current treatment option is a strict, lifelong gluten-free diet, which poses significant challenges due to dietary and social restrictions and the risk of cross-contamination, which leads to persistent intestinal inflammation with villous atrophy in many patients. IMU-856's potential ability to improve the integrity and function of the intestinal barrier represents a promising, novel approach to treat this condition. Importantly, this phase 1b clinical trial is the first study to show that IMU-856 can mitigate the gluten-related effects in celiac disease patients. Based on this result, in conjunction with the drug's favorable safety and tolerability profile, we have concluded that it warrants further clinical investigation.\"\n\"The publication of our phase 1/1b clinical data in healthy human subjects and patients with celiac disease, in such a prestigious peer reviewed journal, confirms that IMU-856's novel mechanism modulating SIRT6, a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, can represent an entirely new approach to treating gastrointestinal diseases,\" added...