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.”