Immunic develops successfully drug for inflammatory bowel disease

Planned Phase 2 ­trial in patients allowed to start


IMU-838 is an orally available, next-generation selective immune modulator. IMU-838 targets intracellular metabolism of activated immune cells by inhibition of the enzyme “dihydroorotate dehydrogenase” (DHODH). With this mode of action, IMU-838 is a potent inhibitor of Th17 and Th1 subsets of T-lymphocytes as well as activated B-cells without potentially increasing the risk of viral infections.

Immunic AG announced that it has received communication from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for its oral investigational drug IMU-838. This will allow Immunic to initiate the Phase 2 trial in patients with ulcerative colitis (UC). This IND approval marks a significant milestone for Immunic. This clinical trial (CALDOSE-1) is the first Phase 2 trial as part of the global development plan with the goal to demonstrate clinical efficacy of IMU-838 for inflammatory bowel disease (IBD). “We are very pleased receiving the swift IND approval from the FDA. This will accelerate our development of IMU-838 as a promising candidate for therapies of chronic inflammatory bowel diseases”, says Dr. Daniel Vitt, CEO of Immunic. “This step underlines that we’re progressing well on our way to deliver a phase III ready product in due time.” Dr. Andreas Mühler, Chief Medical Officer of Immunic adds: “The FDA’s approval of our IND application is a big milestone in developing our selective immune modulator IMU-838 into a globally available drug for the treatment of IBD.”