Innovation Pharmaceuticals Inc (IPIX)

[georgejjl]

In March 2018, Protagonist announced discontinuation of the study following a planned interim analysis conducted by an independent Data Monitoring Committee (DMC). The interim data revealed an unusually high placebo rate of clinical remission (24 percent, approximately four times higher than historical norms for similar UC studies) 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. Results of the complete data set as read by Robarts are summarized below. 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.

https://www.prnewswire.com/news-releases/final-results-from-the-protagonist-propel-study-support-further-clinical-development-of-ptg-100-for-the-treatment-of-ulcerative-colitis-300692199.html

GOD bless,

George