Oral Sulopenem Noninferior to Amoxicillin/Clavulanate for Uncomplicated UTI in Women

Sulopenem etzadroxil/probenecid was found to be noninferior to amoxicillin/clavulanic acid (Augmentin^®) in the treatment of uncomplicated urinary tract infection (uUTI) in adult women, according to data from the phase 3 REASSURE trial.

Sulopenem etzadroxil is an investigational oral penem anti-infective that has been combined with probenecid in a bilayer tablet. The REASSURE trial was conducted to support the approval of the product following a letter from the Food and Drug Administration (FDA) requesting additional study data. 

The phase 3 trial (ClinicalTrials.gov Identifier: NCT05584657) included adult female patients with uUTI; participants were randomly assigned to receive sulopenem etzadroxil 500mg/probenecid 500mg (n=480) or amoxicillin 875mg/clavulanate 125mg (n=442) twice daily for 5 days. The primary endpoint was overall success, defined as clinical success (resolution of uUTI symptoms present at study entry and no new symptoms) and microbiologic success (eradication of the baseline pathogen) at the test of cure visit (day 12 +/- 1 day).

Findings showed treatment with sulopenem/probenecid was statistically superior to amoxicillin/clavulanate; overall success was achieved by 61.7% of the sulopenem/probenecid group and 55% of the amoxicillin/clavulanate group (treatment difference, 6.7%; 95% CI, 0.3-13). In the sulopenem/probenecid arm, 77.3% and 75.2% of patients had clinical success and microbiological success, compared with 76.7% and 66.7% of those in the amoxicillin/clavulanate arm. No new safety signals were reported in the trial. 

“These results bring us one step closer to delivering a much-needed oral treatment option for women suffering from uUTIs,” said Sailaja Puttagunta, MD, Iterum’s Chief Medical Officer. “In addition, we believe these results, along with evidence from our prior phase 3 studies, support the potential of sulopenem in other indications, such as complicated urinary tract infections.” 

The Company is expected to resubmit the New Drug Application for oral sulopenem with this new data in the second quarter of 2024.