Clinical Trial Series to Test Potential Landmark Antibiotic

Urinary tract infections (UTIs) are among the most common infections seen in healthcare, but they don’t necessarily have to be. Pending the results of a series of Phase 3 clinical trials examining the efficacy of an antibiotic indicated for the treatment of gram-negative multi-drug-resistant infections, the industry may soon see the first drug approved for uncomplicated UTIs (uUTIs) in more than 20 years.

According to officials at Iterum Therapeutics, a pharmaceutical company based in Dublin (U.S. headquarters in Chicago), who are awaiting the results of the pivotal trials of the drug sulopenem, more clarity could come prior to the end of 2019.

“What is particularly concerning about the significant prevalence of UTIs is the fact that the current products doctors and patients have been relying on for safe and effective treatment are failing at an increasing rate,” said Corey Fishman, chief executive officer at Iterum. “Because treatment failures pose significant clinical and economic challenges to the healthcare system, we believe the effectiveness of sulopenem against resistant bacteria will solve a significant and growing challenge in the marketplace,” he recently told ADVANCE.

As of Sept. 18, initiation of the second and third trials in the series, known as the Sulopenem for Resistant Enterobacteriaceae (SURE) trial, are underway. In the second trial, intravenous (IV) sulopenem followed by oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) will be compared to IV ertapenem followed by oral ciprofloxacin in adults living with complicated UTIs (cUTIs). In the third trial, IV sulopenem followed by oral sulopenem is compared to IV ertapenem followed by a combination of oral ciprofloxacin and oral metronidazole in adults living with complicated intra-abdominal infections (cIAIs).

Iterum officials expect to file a new-drug application with the U.S. Food & Drug Administration by the end of 2019 and have reportedly received qualified infectious-disease product designations for oral and IV formulations for the treatment of uUTI, cUTI and cIAI.

One of a handful of emerging biopharma companies that continue to target the growing threat of antibiotic resistance while many larger companies are said to not be focusing their efforts on this area of research,1 Iterum has also released details of Phase 1 and Phase 2 trials of sulopenem that demonstrated efficacy and safety versus standard of care (Ciprofloxacin) and targeted spectrum activity against E. coli and K. pneumoniae, the most common causative pathogens for the drug’s target indications.

“The market-leading antibiotics, fluoroquinolones and trimethoprim-sulfamethoxazole, currently have E. coli resistance rates of over 20 percent nationally,” Fishman said. “We are thrilled that oral sulopenem has the potential to be an important treatment option for UTI patients because of its potency against resistant pathogens, as well as its spectrum of antibacterial activity.”

1. LeMieux J. As novartis exits, who will make new antibiotics? Genetic Engineering & Biotechnology News. 2018. Accessed online:

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