Interim Analysis Suggests Wider-than-expected Dosing Range for IMU-838 to Treat Ulcerative Colitis

Interim Analysis Suggests Wider-than-expected Dosing Range for IMU-838 to Treat Ulcerative Colitis
Interim analysis of a Phase 2 clinical trial that's investigating IMU-838 in people with ulcerative colitis (UC) suggests a broader dose range than initially anticipated, announced the therapy's developer, Immunic Therapeutics, in a news release. IMU-838 is an orally available molecule that can inhibit the activity of immune cells called B and T cells. It is currently being investigated as a potential anti-inflammatory therapy for autoimmune diseases, including multiple sclerosis and UC, in an oral tablet formulation. An ongoing Phase 2 clinical trial (NCT03341962), called CALDOSE-1, is evaluating IMU-838 in individuals with mild to severe UC. Participants are being treated with either IMU-838 or a placebo for the first phase of 10 to 22 weeks, followed by a second period of treatment (10 to 22 weeks), depending on the interim analysis. The primary objective is improvement, as assessed by patient-reported outcomes and endoscopy. Three doses of IMU-838 are being tested: 10, 30, and 45 mg per day. Immunic had predicted that 30 mg would be the lowest effective dose, based on preclinical data, but then added the 10 mg dose at the recommendation of the United States Food and Drug Administration. The company had predicted — after about 60 participants
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