Iterum Therapeutics has announced positive topline data from its Phase III REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales (REASSURE) clinical trial, evaluating the efficacy of oral sulopenem in treating uncomplicated urinary tract infections (uUTIs).
The REASSURE trial compared oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) with Augmentin (amoxicillin/clavulanate) in adult women with uUTIs.
The trial met its primary endpoint, showing non-inferiority to Augmentin. It also demonstrated statistical superiority.
The primary endpoint was the overall response at the test-of-cure visit in the microbiological-modified-intent-to-treat susceptible population.
Oral sulopenem achieved an overall success rate of 61.7%, surpassing Augmentin’s 55%.
Both treatments were well tolerated, with less than 1% of patients discontinuing due to adverse events.
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The safety profile for oral sulopenem aligns with previous Phase III trials, with no new safety concerns.
Iterum anticipates resubmitting its New Drug Application (NDA) for oral sulopenem to the US Food and Drug Administration (FDA) in the second quarter of 2024.
If the resubmission addresses all deficiencies noted in the FDA’s complete response letter issued in July 2021, Iterum expects the regulator to complete its review by the fourth quarter of 2024.
Iterum CEO Corey Fishman said: “We are very pleased to announce positive data from this confirmatory trial, which was conducted under a special protocol assessment (SPA) agreement with the FDA.
“We believe there is tremendous value in sulopenem as a potential new oral antibiotic for the uUTI indication, which has over 30 million infections annually in the US, rising resistance to all currently prescribed oral antibiotics, and a complete lack of new product innovation over the last 20 years.”