Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem

--First Oral Penem in the U.S. and Second New Oral Treatment for uUTIs in Over 25 Years, if approved--

--Potential Approval Early Q4 2024--

DUBLIN, Ireland and CHICAGO, April 29, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), 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 that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women.

“The resubmission of the NDA filing for oral sulopenem is a significant step forward in bringing a new antibiotic to the market for women that suffer from an estimated 40 million uUTIs each year in the U.S.,” said Corey Fishman, Chief Executive Officer. “The availability of oral sulopenem, if approved, would mean that physicians and patients have the opportunity to benefit from the proven efficacy and safety of penem antibiotics that, to date in the U.S., have only been available in IV formulations. We look forward to working with the FDA through the review process to advance this much needed treatment option."  

The NDA resubmission includes data from the REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales), SURE (Sulopenem for Resistant Enterobacteriaceae) 1, SURE 2 and SURE 3 phase 3 clinical trials, in which oral sulopenem was well tolerated with no safety issues identified. The REASSURE clinical trial comparing oral sulopenem to oral Augmentin in adult women with a uUTI, demonstrated that oral sulopenem was non-inferior to Augmentin for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with an Augmentin susceptible pathogen, with the difference in the overall success rate demonstrating statistically significant superiority of oral sulopenem versus Augmentin. The SURE 1 clinical trial comparing oral sulopenem to oral ciprofloxacin in adult women with a uUTI, demonstrated statistical superiority of oral sulopenem to the widely used comparator, ciprofloxacin, for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with a quinolone non-susceptible pathogen.