Immunic, Inc. announced the presentation of data from the company's phase 1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), in patients with celiac disease in a moderated poster session at the United European Gastroenterology Week (UEGW) 2023, taking place October 14-17 in Copenhagen. In this phase 1b, double-blind, randomized, placebo-controlled trial in patients with celiac disease, IMU-856 showed positive effects over placebo in four key dimensions of clinical outcome: protection of the gut architecture, improvement of patients' symptoms, biomarker response and enhancement of nutrient absorption. IMU-856 was also found to be safe and well-tolerated with a benign adverse event profile and with pharmacokinetics that allow once-daily dosing.

There were no systematic clinically relevant findings relative to safety and tolerability, as assessed by physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiograms. IMU-856 is an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, the compound may represent a unique treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, inflammatory bowel disease, irritable bowel syndrome with diarrhea and other intestinal barrier function associated diseases. Immunic believes that, because IMU-856 has been shown in preclinical investigations to avoid suppression of immune cells, it may therefore have the potential to maintain immune surveillance for patients during therapy, an important advantage versus immunosuppressive medications.

IMU-856 demonstrated positive results in a phase 1b clinical trial in celiac disease patients in four key dimensions of the disease's pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. Currently, the company is preparing for phase 2 clinical testing in this patient population. IMU-856 is an investigational drug product that has not been approved in any jurisdiction.