Iterum Initiates SURE 2 and SURE 3 Phase 3 Clinical Trials of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections

Iterum Therapeutics (Nasdaq:ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the second and third of three planned Phase 3 clinical trials for sulopenem, Iterum’s lead compound and novel antibiotic for the treatment of gram-negative, multi-drug resistant infections.

As quoted in the press release:

In the second trial, known as Sulopenem for Resistant Enterobacteriaceae (SURE) 2, IV sulopenem followed by oral sulopenem etzadroxil combined with probenecid in a bilayer tablet (oral sulopenem) will be compared to IV ertapenem followed by oral ciprofloxacin in adults with complicated urinary tract infections (cUTI). In the third trial, known as SURE 3, IV sulopenem followed by oral sulopenem is compared to IV ertapenem followed by a combination of oral ciprofloxacin and oral metronidazole in adults with complicated intra-abdominal infections (cIAI).

“We are excited to initiate SURE 2 and SURE 3, our remaining Phase 3 clinical trials for sulopenem, providing three indications at launch, if approved,” said Corey Fishman, Chief Executive Officer of Iterum. “The initiation of these trials, together with SURE 1, which we initiated in early August, means that our entire Phase 3 clinical program for sulopenem is currently underway. Given this achievement, we reiterate our expectation of announcing top-line data from all three trials in the second half of 2019 and U.S. regulatory submissions by the end of 2019. We believe we are setting the stage for a series of value-creating, near-term milestones for Iterum that will be funded by our current cash resources.”

“Multi-drug resistant cUTIs and cIAIs represent an important unmet medical need given the rising incidence of resistant infections and the paucity of new treatment options, particularly for oral step-down therapy,” said Michael Dunne, M.D., Chief Scientific Officer of Iterum. “With slowing industry development of new classes of antibiotics, new treatment options are much needed as a solution to the rising rate of resistance to current antibiotics, particularly fluoroquinolones.”

Click here to read the full press release.