Iterum Therapeutics plc 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 NDA resubmission includes data from the REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales), SURE (Sulopenem or 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. Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter (CRL) the Company received from the FDA in July 2021, the Company expects that the FDA will complete its review and take action six months from the date the FDA received the resubmitted NDA (or early in the fourth quarter of 2024).