PROTAGONIST THERAPEUTICS,INC. (NASDAQ:PTGX) Files An 8-K Other EventsItem 8.01. Other Events.
Protagonist Therapeutics,Inc. (the “Company”) today announced that it 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 (the “Study”). This decision followed a planned interim analysis by an independent Data Monitoring Committee (the “DMC”) of the 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. 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 Study.