Protagonist Therapeutics Inc. is terminating a study designed to establish the effectiveness of its drug PTG-100 to treat ulcerative colitis, an inflammatory bowel disease.
The Neward, Calif.-based biopharmaceutical company's stock price was down 41.75% to $11.90 per share in premarket trading March 26.
Protagonist Therapeutics' decision was prompted by the findings of the study's independent data monitoring committee that said the phase 2b trial — known as Propel — was "futile."
The committee based its conclusion on the efficacy and safety data from the first 65 patients of the 240 subjects enrolled in the trial to study the number of patients whose symptoms or active disease went away.
"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," Protagonist Therapeutics President and CEO Dinesh Patel said in a statement.
Protagonist Therapeutics will postpone the initiation of a phase 2/3 clinical trial of PTG-100 in patients with chronic pouchitis until a full review is conducted on the findings from the Propel study.