Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem for the Treatment of Uncomplicated Urinary Tract Infections

Sulopenem demonstrates superiority in treatment of patients with quinolone resistant pathogens

Company to discuss NDA filing with FDA

DUBLIN, Ireland and CHICAGO, June 29, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced topline results from its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial for the treatment of Uncomplicated Urinary Tract Infections (uUTI). Sulopenem is a novel anti-infective compound that, if approved, would be the first penem antibiotic with an oral formulation indicated for treatment of uUTI.

In SURE1, there were two independent primary endpoints, with achievement of either of those endpoints expected to provide a potential path to marketing approval based on previous discussions with the U.S. Food and Drug Administration (FDA).  In the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing substantial evidence of a treatment effect in patients with uUTI. With a p-value of <0.001, this result was highly statistically significant. In the second population of patients with organisms susceptible to quinolones, sulopenem was not non-inferior to ciprofloxacin and did not achieve the related primary endpoint, with the difference in outcomes driven by the rate of asymptomatic bacteriuria post treatment.  In SURE1, sulopenem was well tolerated with a favorable safety profile, consistent with the SURE2 and SURE3 trials.

“We are extremely pleased to have a potential path to approval for sulopenem in uUTI.  Approximately 5-6 million urinary tract infections in the U.S. every year are caused by quinolone resistant pathogens. If approved, sulopenem would provide a treatment option for women with infections due to these resistant pathogens,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. “Sulopenem is the first new oral antibiotic to demonstrate success in treating uUTIs in a phase 3 trial in over twenty years.” Mr. Fishman continued, “We anticipate a pre-NDA meeting with the FDA in the third quarter of 2020 to discuss a path forward.”