Protagonist announces results from re-analysis fo Phase 2 Propel study
Protagonist Therapeutics announced results from an independent blinded re-analysis of the Phase 2 PROPEL study of oral alpha-4-beta-7 integrin antagonist PTG-100 for the treatment of patients with ulcerative colitis, UC. No safety concerns were noted with PTG-100. The data from blinded endoscopy re-reads and a comprehensive data review provide signals of clinical efficacy and support further development of PTG-100. In March Protagonist announced discontinuation of the study following a planned interim analysis conducted by an independent Data Monitoring Committee. The interim data revealed an unusually high placebo rate of clinical remission that led to a futility decision and discontinuation of the trial. A re-read of the endoscopies by the CRO's subcontractor and a subsequent fully blinded re-read of the endoscopies by an independent third party, Robarts Clinical Trials, confirmed that a subset of the initial endoscopy reads provided by the CRO were in error. If the re-read of endoscopy results had been utilized for the interim futility analysis, the trial would have continued. In addition, improvements observed in independent, blinded histological scores favor PTG-100 over placebo and correlate with the clinical remission and endoscopic response outcomes from the re-analysis.