Iterum Initiates SURE 1, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Iterum Therapeutics (Nasdaq:ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the first of three Phase 3 clinical trials.

As quoted in the press release:

“We are delighted to begin our first Phase 3 clinical trial for sulopenem early in the third quarter, consistent with our prior guidance. The commencement of our Phase 3 program marks an important milestone for our company,” said Corey Fishman, Chief Executive Officer of Iterum. “We are leveraging our prior clinical trial data, and the important feedback we received from the FDA and European regulators, to conduct our Phase 3 trials, with data expected to readout in the second half of 2019. If approved, oral sulopenem would be the first new drug approved for uncomplicated UTIs in over 20 years and would provide a much-needed treatment option in a large and growing market.”

“Multi-drug resistance in UTIs is alarmingly high and growing globally, and current treatment options are failing,” said Michael Dunne, M.D., Chief Scientific Officer of Iterum. “In particular, resistance to fluoroquinolones continues to rise. Healthcare providers and their patients urgently need new oral options to effectively treat infections in the community such as UTIs. The U.S. Food and Drug Administration (FDA) has recently strengthened existing warnings for the fluoroquinolone class and maintains that healthcare professionals should not prescribe fluoroquinolones to patients who have other treatment options for uUTI as the risks outweigh the benefits.”

Click here to read the full press release.