Drug Development, Setbacks

Protagonist aborts lead ulcerative colitis program after drug fizzles in PhIIb, stock craters

The lead therapy at Protagonist has flunked a mid-stage trial, pushing the Newark-based company to pull the plug on its ulcerative colitis drug PTG-100.

The news is tanking the company’s stock $PTGX, which is down nearly 60% in pre-market trading.

The decision came after an interim analysis of a Phase IIb study, which found 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 results were disappointing enough for Protagonist to postpone its decision about starting a Phase II/III study of PTG-100 in chronic pouchitis until after the full review of the interim data.

Dinesh Patel

“We are very disappointed with this futility-based outcome which was also accompanied by an unexpectedly high placebo rate,” said the company’s president and CEO Dinesh Patel in a statement. “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. We are very grateful to the patients and investigators who participated in the Propel trial.”

The company noted that it was still hopeful on its other peptide-based assets, PTG-200 and PTG-300, the former of which is partnered with J&J in a deal that got Protagonist a $50 million upfront payment and milestones of $940 million.


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