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FDA Approves Phase 2 Study of Ulcerative Colitis Drug Candidate
Immunic Therapeutics announced that the FDA has approved an investigational new drug application for IMU-838, clearing the drug for a phase 2 study in patients with ulcerative colitis.
“This will accelerate our development of IMU-838 as a promising candidate for therapies of chronic inflammatory bowel diseases,” Daniel Vitt, PhD, CEO of Immunic said. “This step underlines that we’re progressing well on our way to deliver a phase 3 ready product in due time.”
IMU-838 is an orally available selective immune modulator that targets intracellular metabolism of activated immune cells by inhibition of the enzyme dihydroorotate dehydrogenase, according to the press release.
Immunic plans to initiate a phase 2 trial in Europe and the U.S. to test the efficacy of IMU-838 against a placebo. The company is also preparing another trial for the treatment of patients with Crohn’s disease, which will commence after receiving interim data from the ulcerative colitis trial, per the press release.
“The FDA’s approval of our [investigational new drug (IND)] application is a big milestone in developing our selective immune modulator IMU-838 into a globally available drug for the treatment of IBD,” Andreas Mühler, MD, chief medical officer of Immunic said in the press release. “This IND approval is a validation of Immunic’s development strategy and an important step for commencing this large international trial.” – by Alex Young
Disclosures: Vitt and Mühler are employed by Immunic.