The trial compared oral sulopenem to Augmentin in adult women with uncomplicated urinary tract infections. Credit: 220 Selfmade studio/shutterstock.com.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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%.

See Also:

Both treatments were well tolerated, with less than 1% of patients discontinuing due to adverse events.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”