Targeting Intestinal Barrier Function
IMU-856, which Immunic believes to be novel and highly innovative, is an orally available, small molecule modulator that targets a protein which serves as a transcriptional regulator of the intestinal barrier function. Immunic has not yet disclosed the molecular target for IMU-856. Based on preclinical data, Immunic believes this compound appears to represent a novel and potentially paradigm-shifting treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function in patients suffering from diseases like inflammatory bowel disease, diarrhea-predominant irritable bowel syndrome, immune checkpoint inhibitor induced colitis and other intestinal barrier function associated diseases. Immunic believes that because IMU-856 avoids suppression of the immune functions, it should therefore maintain immune surveillance for patients.
A double-blind, randomized, placebo-controlled clinical phase 1 study comprised of three parts is currently ongoing. The first part is a single ascending dose portion in healthy volunteers, which is planned to be followed by a second, multiple ascending dose part in healthy volunteers, with IMU-856 given daily for 14 consecutive days. These first two parts of the phase 1 trial are designed to assess the safety, tolerability and pharmacokinetic properties of IMU-856. In a third part of the phase 1 trial, the study drug would be given daily over 28 consecutive days at two different dose levels in patients with diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn’s disease who were screened for increased bowel permeability using oral marker tests. The change in bowel permeability, using a 2-sugar test to monitor therapeutic effects, would be evaluated as a pharmacodynamic marker, and include a comparison of two active dose groups to placebo. Additionally, biomarker, safety and trough plasma concentration levels would also be assessed.
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 an exclusive global option to obtain the exclusive right to license a group of compounds, designated by Immunic as IMU-856. Under this agreement, Immunic has the rights to commercialization of IMU-856 in all countries, including the United States, Europe and Japan. The option 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.