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 intestinal barrier function. Immunic has not yet disclosed the molecular target for IMU-856. Based on preclinical data, Immunic believes this compound represents a new and potentially disruptive 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 and progressing. 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 safety, pharmacodynamics and pharmacokinetics of IMU-856. Immunic plans to extend these studies to include patients with several diseases involving bowel barrier dysfunction. Unblinded safety data from the SAD and MAD parts in healthy volunteers is expected to be available in the second half of 2021. Initiation of the third portion of the phase 1 trial in patients with several diseases involving bowel barrier dysfunction is expected in the second half of 2021.
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.