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ARTICLE | Clinical News

New Phase IIb analyses support further development of Protagonist's UC candidate

August 17, 2018 3:14 AM UTC

Protagonist Therapeutics Inc. (NASDAQ:PTGX) said new analyses from the discontinued Phase IIb PROPEL trial of PTG-100 to treat moderate to severe ulcerative colitis showed that the initial findings by an IDMC were "an unfortunate consequence of a human error in the endoscopy readouts by the CRO."

Protagonist discontinued the double-blind, international trial in March after a planned interim analysis by an IDMC determined the trial to be futile based on the primary endpoint of Mayo score clinical remission in the first 65 patients who completed 12 weeks of treatment. The company said the interim data showed an unusually high clinical remission rate of 24% in the placebo arm (see “Protagonist Discontinues Phase IIb of PTG-100 for UC”)...

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Integrin alpha(4)beta(7)