Based on the DMC's recommendation received after the market close on Friday, and while further review of the data is being conducted, Protagonist is notifying PROPEL trial investigators that randomization of potential participants and further treatment of patients currently in the study will be discontinued. Additionally, the Company will postpone its decision about the initiation of a Phase 2/3 clinical trial of PTG-100 in chronic pouchitis until after its full review of the interim data from the UC PROPEL study.
"We are very disappointed with this futility-based outcome which was also accompanied by an unexpectedly high placebo rate. We will conduct an extensive review of the complete dataset on the totality of patients enrolled in the trial before making any further decisions about the future development of PTG-100," said
About the Phase 2b PROPEL Trial
The Phase 2b PROPEL trial is a global, randomized, double-blind, placebo-controlled, two-stage adaptive clinical trial to assess the safety, efficacy, and dose-optimization of three doses (150mg, 300mg, or 900mg) of PTG-100 compared to placebo for 12 weeks in patients with moderate to severe ulcerative colitis. The primary efficacy endpoint of the study is the proportion of patients who achieve clinical remission as defined by rectal bleeding, stool frequency, and endoscopic subscores of the Mayo score.
Conference Call and Webcast Information
Protagonist executives will host a conference call at
Protagonist Therapeutics is a clinical stage biopharmaceutical company that utilizes a proprietary technology platform to discover and develop novel peptide-based drugs to transform existing treatment paradigms for patients with significant unmet medical needs. PTG-100 is an oral alpha-4-beta-7 integrin antagonist peptide that was being developed for inflammatory bowel diseases (IBD). The company's interleukin-23 receptor antagonist peptide, PTG-200, is currently being studied in a Phase 1 clinical trial in healthy volunteers to support further development in Crohn's disease. The IL-12/23 pathway blockade is an approach that has been validated through an
Protagonist is headquartered in Newark, California, with pre-clinical and clinical staff in California and discovery operations in both California and Brisbane, Queensland,
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