IMU-856

IMU-856 is an orally available and systemically acting small molecule modulator that targets Sirtuin 6, or SIRT6, 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 was discovered by Daiichi Sankyo. In November 2018, Immunic and Daiichi Sankyo entered into a global option and license agreement, granting Immunic the exclusive right to license IMU-856. Under this agreement, Immunic has the rights to commercialization of IMU-856 in all countries. Immunic exercised the option in January 2020.

A double-blind, randomized, placebo-controlled phase 1 clinical trial of IMU-856 comprised of three parts was completed. In September 2022, Immunic announced positive results from Part A (single ascending doses, or SAD) and Part B (multiple ascending doses, or MAD) of the trial in healthy human subjects. The data revealed a favorable safety, tolerability and pharmacokinetic profile for IMU‑856 in single and 14-day multiple dosing. No maximum tolerated dose was reached and the investigated doses are expected to exceed the required therapeutic dosing of IMU-856.

In May 2023, Immunic announced positive results from the Part C portion of the trial in patients with celiac disease. IMU-856 demonstrated positive results in four key dimensions of the disease’s pathophysiology: histology, disease symptoms, biomarkers and nutrient absorption. IMU-856 was also observed to be safe and well-tolerated in this trial. Immunic believes that this data set provides initial clinical proof-of-concept for an entirely new therapeutic approach to gastrointestinal disorders by promoting regeneration of bowel architecture. Phase 2 clinical testing in this patient population is currently in preparation.