Iterum Therapeutics Plc (ITRM) made an announcement on Tuesday, highlighting the successful completion of its Phase 3 REASSURE clinical trial. The trial focused on the assessment of Sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Resistant Enterobacterales. The trial achieved its primary target by demonstrating Sulopenem as not only being non-inferior to Augmentin, but also statistically superior to it.
In the study, oral Sulopenem (a combination of sulopenem etzadroxil and probenecid in a dual-layered tablet) was compared to oral Augmentin (amoxicillin/clavulanate) in adult women diagnosed with uncomplicated uUTIs. The results showed an overall success rate of 61.7% in patients treated with oral Sulopenem, significantly higher than the 55.0% success rate in patients treated with Augmentin.
Additionally, no serious adverse events were reported among the patients who received oral Sulopenem. Comparatively, there were five serious adverse events reported among patients treated with Augmentin, although none of these were drug-related.
Iterum Therapeutics also plans to resubmit its New Drug Application for Sulopenem, intended for the treatment of uUTIs, in the second quarter of 2024.
