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Protagonist Therapeutics (PTGX) Discontinues Phase 2b PROPEL Trial of PTG-100 for the Treatment of Ulcerative Colitis following Interim Analysis

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Additional Relevant Details The Company is discontinuing the Phase 2b PROPEL study of PTG-100, its investigational oral GI-restricted alpha-4-beta-7 integrin antagonist peptide, in patients with moderate to severe ulcerative colitis (UC). This decision followed a planned interim analysis by an independent Data Monitoring Committee (DMC) of unblinded efficacy and safety data from the first 65 patients from the ongoing 240 patient trial who had completed the 12 week treatment with PTG-100. Using pre-specified criteria, the DMC deemed the trial to be futile based on an analysis of the primary endpoint of clinical remission. No safety concerns were noted in the analysis.
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Occurred on:
Mar 26, 2018
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Related Keywords Ptg-100, Ulcerative Colitis