Iterum Therapeutics plc (NASDAQ:ITRM) has announced topline results of its third phase clinical trial evaluating oral and intravenous sulopenem in the treatment of complicated urinary tract infection (cUTI).
Iterum’s sulopenem study fails to meet endpoints
The company indicated that the results show that sulopenem did not attain statistical non-inferiority compared to ertapenem on the SUlopenem for Resistant Enterobacteriaceae (SURE) 2 clinical study in cUTI. The FDA’s endpoint was overall microbiologic and clinical response on the 21st date in the micro-mITT population as assessed by the 10% non-inferiority margin.
The multi-center, double-masked, randomized SURE 2 clinical study enrolled around 1,395 participants. The study aimed to measure the safety, efficacy, and tolerability of oral and IV sulopenem in the treatment of cUTI. The study was randomized with participants receiving either IV sulopenem once per day for at least five days, followed by twice per day oral sulopenem for seven to ten days or IV ertapenem once per day for five days. The ertapenem dose was then followed by either amoxicillin-clavulanate twice per day, oral ciproflaxins, or quinolone-resistant isolates.
Sulopenem’s cure response rate was 67.8%
The test of cure response rate for sulopenem was 67.8%, and that of ertapenem was 73.9%. The difference in the percentage of response rates was mainly due to the high rates of asymptomatic bacteriuria compared to ertapenem, which were evident at the cure visit test. On the other hand, the rate of participants receiving more antibiotics or those that showed residual cUTI signs was the same. Interestingly the clinical response at the test cure in Clinically Evaluable and mITT populations was the same for sulopenem and ertapenem.
Corey Fishman, the CEO of Iterum Therapeutics, indicated they were disappointed by the SURE study outcome. This is despite sulopenem showing safety and tolerability that was consistent with prior trials as well as the penem class. Corey added that, based on the results, the company was evaluating its strategic, corporate, and financial options as they sought to manage the remaining resources prudently to drive shareholder value.