IMU-856

IMU-856: Targeting Intestinal Barrier Function

IMU-856 is an orally available and systemically acting small molecule modulator that targets a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium.

IMU-856, which Immunic believes to be novel, is an orally available, small molecule modulator that targets a protein which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Immunic has not yet disclosed the molecular target for IMU-856. Based on preclinical data, the compound may represent a new 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 maintain immune surveillance for patients during therapy, an important advantage versus chronic treatment with potentially immunosuppressive medications.

A double-blind, randomized, placebo-controlled phase 1 clinical trial comprised of three parts is currently ongoing. The first part, a single ascending dose portion in healthy volunteers, has been completed. The second, multiple ascending dose part in healthy volunteers, with IMU-856 given daily for 14 consecutive days, is currently ongoing.

These first two parts of the phase 1 trial are designed to assess safety, pharmacodynamics and pharmacokinetics of IMU-856. Unblinded safety data from the single and multiple ascending parts in healthy volunteers is expected to be available in the third quarter of 2022.

The third part of the phase 1 clinical trial is structured as a 28-day, double-blind, placebo-controlled trial designed to assess the safety and tolerability of IMU-856 in patients with celiac disease during periods of gluten-free diet and gluten challenge. Secondary objectives include pharmacokinetics and disease markers, including those evaluating gastrointestinal architecture and inflammation.

IMU-856 was discovered and initially developed 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. The license also includes exclusivity on a patent application filed by Daiichi Sankyo, covering IMU-856’s composition of matter. Immunic exercised the option in January 2020.