Iterum Therapeutics's Late-stage REASSURE Trial Successfully Met Primary Endpoint

(RTTNews) - On Tuesday, Iterum Therapeutics plc (ITRM) announced that its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial successfully met the primary endpoint of non-inferiority to Augmentin and demonstrated statistical superiority.

The trial compared oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTIs).

Additionally, oral sulopenem achieved overall success in 61.7% of patients compared to 55.0% for Augmentin, signifying statistically significant superiority over Augmentin. No serious adverse events (SAE) were reported in patients receiving oral sulopenem, while five SAEs occurred in patients receiving Augmentin, with no drug-related SAEs.

The company also intends to resubmit its New Drug Application (NDA) for oral sulopenem to treat uUTI in the second quarter of 2024.