Immunic presents data on IMU-856 at Crohn’s and colitis conference

NEW YORK—December saw Immunic Inc., a clinical-stage biopharmaceutical company focused on developing oral therapies for the treatment of chronic inflammatory and autoimmune diseases, announce that Dr. Hella Kohlhof, the company’s chief scientific officer, presented data on IMU-856 for the first time at the IBD Innovate: Product Development for Crohn’s and Colitis conference hosted by the Crohn’s and Colitis Foundation.

The presentation, entitled, “IMU-856: A Small Molecule Modulator Restoring the Gut Barrier Function,” was given as part of the “Small & Large Molecules” session that showcased innovative product development programs in inflammatory bowel disease (IBD). Kohlhof’s presentation highlighted the potential of IMU-856 to revolutionize the treatment of multiple diseases related to intestinal barrier function.

IMU-856, which Immunic believes to be novel and highly innovative, is an orally available, small-molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of the intestinal barrier function. Based on preclinical data, the compound appears to represent a new and potentially disruptive approach for the treatment of intestinal diseases by potentially restoring the intestinal barrier function while maintaining immunocompetency.

Highlights of the presentation included:

• IMU-856 is an epigenetic regulator that appears to influence the tightly regulated network of genes and proteins associated with intestinal epithelial cell interaction and adhesion

• IMU-856 has shown target modulation at very low concentrations in both cellular and non-cellular models

• Preclinical data demonstrates that IMU-856 is able to restore intestinal barrier function in cytokine challenged Caco-2 cells and shows dose-depending activity in several dextran sulfate sodium-induced colitis mouse models

“We are excited to present, for the first time, strong preclinical data of IMU-856 which shows potential significant advantages over current immunosuppressive treatments for intestinal barrier function-associated diseases. IMU-856 appears to have a unique targeted ability to strengthen the intestinal barrier function, and we believe that a normalized intestinal barrier function may avoid bacterial triggers without impairing the immune system,” said Kohlhof in a news release announcing the presentation. “This early data, therefore, further supports our belief that IMU-856 has the ability to change the treatment paradigm for patients suffering from a variety of gastrointestinal diseases. We look forward to learning more about the pharmacokinetics and safety of IMU-856 in our Phase 1, single and multiple ascending dose studies, which we expect to initiate in the first half of 2020. We also plan to extend these studies to assess safety and mechanism-related biomarkers in patients suffering from diseases related to intestinal barrier function. We are hopeful that future clinical trials will validate IMU-856 as a safe, long-term treatment option for these patients.”

IMU-856 was discovered and developed by Daiichi Sankyo Co. Ltd.. 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. Immunic plans to execute the option prior to entering Phase 1 clinical development.