This article is more than 5 years old. Information may no longer be current.
Protagonist discontinues phase 2 trial of oral UC drug candidate
Click Here to Manage Email Alerts
Protagonist Therapeutics announced it will discontinue the phase 2b PROPEL study of PTG-100, an oral GI-restricted alpha-4-beta-7 integrin antagonist peptide under investigation for the treatment of patients with moderate to severe ulcerative colitis.
The decision follows a planned interim analysis by an independent data monitoring committee that determined the trial was futile based on analysis of the primary endpoint of clinical remission, according to a press release. The monitoring committee based the interim analysis on unblinded efficacy and safety data from the first 65 patients in the trial who completed 12 weeks of treatment with PTG-100.
“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,” Dinesh V. Patel, PhD, president and CEO of Protagonist said in the press release. “Protagonist remains committed to progressing its other peptide-based assets currently in clinical development, PTG-200 and PTG-300, and to discovering new peptide-based therapeutic entities to address significant unmet medical needs.”
Protagonist is notifying investigators about the discontinuation of the trial and will postpone its decision about the start of a phase 2/3 trial of PTG-100 in chronic pouchitis until after completion of the full review of the PROPEL interim data, according to the press release.
Disclosures: Patel is employed by Protagonist.