Positive Phase 3 Results for Iterum's Sulopenem in Treating uUTIs

Iterum Therapeutics, a pharmaceutical firm in the clinical stage, has reported positive findings from the Phase 3 REASSURE clinical trial of its oral antibiotic sulopenem. The trial compared the efficacy of sulopenem to that of Augmentin® in treating uncomplicated urinary tract infections (uUTIs) in adult women. The results showed that sulopenem was not only non-inferior to Augmentin but also demonstrated statistical superiority.

The trial's primary endpoint was the overall response, which includes clinical cure and microbiologic eradication, at the test-of-cure visit in the susceptible population. Sulopenem achieved an overall success rate of 61.7%, outperforming Augmentin's 55.0%. The trial data indicated that sulopenem was well tolerated, with adverse event rates leading to discontinuation less than 1% for both treatments. No serious adverse events related to sulopenem were reported.

Iterum Therapeutics is planning to resubmit the New Drug Application (NDA) for sulopenem to the FDA in 2024's second quarter. The company is also considering strategic options to maximize stakeholder value, including selling or licensing the rights to sulopenem. The drug has the potential to be the first oral penem antibiotic approved in the U.S., addressing a significant need for new oral antibiotics to treat uUTIs, which affect over 30 million people annually and are becoming increasingly resistant to existing treatments.

The REASSURE trial was a double-blind study involving 2,222 patients, designed to evaluate the efficacy, tolerability, and safety of sulopenem compared to Augmentin. The trial's design and results are expected to be presented at a future scientific meeting.

Urinary tract infections are prevalent, with half of all women experiencing at least one uUTI in their lifetime. The rise in antibiotic resistance has complicated treatment options, making the development of new antibiotics like sulopenem crucial.

Iterum Therapeutics is committed to developing anti-infectives to combat multi-drug resistant pathogens. Sulopenem, the company's lead compound, has shown potent activity against various bacteria, including those resistant to other antibiotics. The company has received both Qualified Infectious Disease Product (QIDP) and Fast Track designations for sulopenem's oral and IV formulations for several indications.