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Iterum's antibiotic sulopenem narrowly misses goal of late-stage study

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Iterum's antibiotic sulopenem narrowly misses goal of late-stage study

Iterum Therapeutics PLC's antibiotic sulopenem did not perform better than Merck & Co. Inc.'s Invanz in treating complicated intra-abdominal infections in a late-stage study.

The phase 3 study, dubbed Sure 3, enrolled 668 patients with different intra-abdominal infections. These complicated infections extend from a gastrointestinal source, such as the appendix or the colon, into the peritoneal space and can be associated with abscess formation.

According to the Irish pharmaceutical company, sulopenem narrowly missed the study's main goal, producing a clinical response in 85.5% of patients by day 28 compared to 90.2% for Invanz, or ertapenem. Drug-related adverse events were reported in 6.0% and 5.1% of patients on sulopenem and Invanz, respectively, with diarrhea being the most common. Treatment was discontinued in 1.5% of patients on sulopenem compared to 2.1% on Invanz.

The U.S. Food and Drug Administration previously granted sulopenem special protocol agreements, qualified infectious disease product status and fast track designation for oral and IV sulopenem for the treatment of community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis and pelvic inflammatory disease.

Iterum's stock was down by 38.14% to $3 as of 5:21 p.m. ET.