Iterum Therapeutics Resubmits NDA for Oral Sulopenem to Treat Uncomplicated UTIs
Key Insights
Iterum Therapeutics (search) has resubmitted its New Drug Application (NDA) to the FDA for oral sulopenem, targeting uncomplicated urinary tract infections (search) (uUTIs) in adult women.
The resubmission includes data from Phase 3 trials (REASSURE, SURE 1, SURE 2, SURE 3) demonstrating oral sulopenem's efficacy and safety compared to Augmentin and ciprofloxacin.
If approved, oral sulopenem could be the first oral penem antibiotic in the U.S., offering a new treatment option for the estimated 40 million uUTIs annually.
Iterum Therapeutics (search) plc has announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem). The drug is intended for the treatment of uncomplicated urinary tract infections (search) (uUTIs) in adult women. This action follows a previous complete response letter (CRL) from the FDA in July 2021, and the company anticipates a decision by early in the fourth quarter of 2024, assuming the resubmission adequately addresses the identified deficiencies.
Clinical Trial Data
The NDA resubmission incorporates data from the REASSURE, SURE 1, SURE 2, and SURE 3 Phase 3 clinical trials. These trials evaluated the safety and efficacy of oral sulopenem. The REASSURE trial, which compared oral sulopenem to oral Augmentin in women with uUTIs, demonstrated that sulopenem was non-inferior to Augmentin for the primary efficacy endpoint: clinical and microbiologic response at the test-of-cure visit in patients with an Augmentin-susceptible pathogen. Notably, the overall success rate showed statistically significant superiority for oral sulopenem compared to Augmentin.
The SURE 1 trial compared oral sulopenem to oral ciprofloxacin in adult women with uUTIs. Results indicated that sulopenem was statistically superior to ciprofloxacin for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit among patients with a quinolone non-susceptible pathogen.
Potential Impact
According to Corey Fishman, Chief Executive Officer, the resubmission is a significant step toward providing a new antibiotic option for women, who experience an estimated 40 million uUTIs annually in the U.S. If approved, oral sulopenem would be the first oral penem antibiotic available in the U.S., potentially offering physicians and patients the benefits of penem antibiotics, which have previously only been accessible in IV formulations.
About Sulopenem
Sulopenem is a novel penem anti-infective compound under Phase 3 clinical development in both oral and IV formulations. It has demonstrated potent in vitro activity against a wide range of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics. Both oral and IV formulations of sulopenem have received Qualified Infectious Disease Product (QIDP) and Fast Track designations for seven indications.