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- FDA has granted IND approval for Immunic’s oral investigational drug IMU-838
- Active IND allows Immunic to proceed with Phase 2 clinical trial (CALDOSE-1)
- Patients with active ulcerative colitis will be treated following randomization to multiple doses of IMU-838 or placebo
Immunic AG (Immunic Therapeutics), a clinical stage biotech company in Martinsried near Munich, Germany, today 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).
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