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.
About PROTAGONIST THERAPEUTICS,INC. (NASDAQ:PTGX)
Protagonist Therapeutics, Inc. is a clinical-stage biopharmaceutical company with a peptide technology platform focused on discovering and developing new chemical entities (NECs) to address significant unmet medical needs. The Company’s product pipeline includes PTG-100, PTG-200 and PTG-300. Its primary focus is on developing oral peptide drugs that target biological pathways also targeted by marketed injectable antibody drugs. PTG-100 is an oral, alpha-4-beta-7 (a4b7) integrin-specific antagonist peptide product candidate, which has completed a Phase I clinical trial in normal healthy volunteers (NHVs). PTG-100 is being developed for treatment of moderate-to-severe ulcerative colitis (UC). PTG-200 is an oral Interleukin-23 receptor (IL-23R) antagonist being developed for moderate-to-severe Crohn’s disease (CD). PTG-200 is in investigational new drug (IND) enabling studies. PTG-300 is an injectable hepcidin mimetic for treatment of iron overload related rare diseases.