Iterum Therapeutics has commenced the first Sulopenem for Resistant Enterobacteriaceae (SURE) trial, a Phase lll study of oral sulopenem against oral ciprofloxacin for the treatment of adult women with uncomplicated urinary tract infections (uUTI).
The randomised, multi-centre, double-blind trial is designed to measure efficacy, tolerability, and safety of the trial drug combination among around 1,364 patients.
To be performed under a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA), the SURE 1 trial will randomise the enrolled patients to receive either oral sulopenem twice daily for five days or oral ciprofloxacin twice daily for three days.
The trial’s primary endpoint is overall success, including combined clinical and microbiological success.
Secondary endpoints of the trial are microbiologic success in each study arm in the microbiologically evaluable population.
Top-line results from the trial are expected in the second half of next year.
Iterum Therapeutics chief scientific officer Michael Dunne said: “Multi-drug resistance in UTIs is alarmingly high and growing globally, and current treatment options are failing.
“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 US 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.”
UTI is one of the most common bacterial infections of bladder that primarily attacks women.
Up to 10% of women are estimated to have a urinary tract infection in a given year, while 50% of all women experience at least one UTI at some point in their lives.