Iterum Therapeutics Announces Completion of Enrollment in Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infection

Topline results expected in Q1 2020

DUBLIN, Ireland and CHICAGO, Dec. 26, 2019 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the completion of patient enrollment in its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial in uncomplicated urinary tract infections (uUTI).

“We are pleased to announce the completion of enrollment in our final phase 3 trial for uncomplicated urinary tract infections (uUTI) with over 1,670 patients treated. Topline results from this trial are expected in the first quarter of 2020,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. “It has been over 20 years since a new, oral treatment has been developed for urinary tract infections and the existing orals are no longer effective.  If approved, oral sulopenem will provide an option to those patients with an elevated risk for treatment failure that currently have no other alternatives.”

This multi-center, double-blind clinical trial is measuring efficacy, tolerability, and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women. Patients are randomized to receive either oral sulopenem/probenecid twice daily for 5 days of treatment, or oral ciprofloxacin twice daily for three days of treatment. 

About Uncomplicated Urinary Tract Infections

There are approximately 13.5 million emergency room and office visits for symptoms of UTIs and approximately 21 million uUTIs in the United States annually. Based on market research, physicians estimated that approximately 35% of these patients are at elevated risk for treatment failure. Proper antibiotic treatment of drug-resistant infections in this group is particularly important due to the consequences associated with treatment failure. Elevated risk patients were defined in the research as patients with recurrent UTIs, elderly patients, patients who have a suspected or confirmed drug-resistant infection, patients with comorbidities (e.g., Diabetes mellitus) or that are immunocompromised, patients that have had a recent hospitalization, patients with a history of prior antibiotic failure and patients in a long-term care setting.