Iterum Therapeutics’ sulopenem shows positive results in urinary infections

Iterum Therapeutics announced positive topline results from its REASSURE Phase 3 clinical trial comparing oral sulopenem to oral Augmentin in adult women with uncomplicated urinary tract infections. With the positive data from this trial, Iterum plans to resubmit its New Drug Application for oral sulopenem for the treatment of uUTI in Q2. At the same time, Iterum will focus on selling, licensing, or otherwise disposing of its rights to sulopenem with the goal of maximizing value for its stakeholders. Results demonstrate that oral sulopenem was non-inferior to Augmentin with respect to the trial’s primary endpoint, overall response at the test-of-cure visit in the microbiological-modified-intent-to-treat susceptible population. Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin, demonstrating statistically significant superiority of oral sulopenem versus Augmentin. Both oral sulopenem and Augmentin were well tolerated in this study with discontinuations due to adverse events occurring in less than1% of patients on both regimens. No serious adverse events were reported in patients receiving oral sulopenem, while five SAEs occurred in patients receiving Augmentin, with no drug-related SAEs. The safety profile for oral sulopenem was consistent with those observed in each of the previously conducted Phase 3 trials, with no new safety signals noted beyond those associated with beta-lactams. Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA, or during Q4.