Shares in Dublin, Ireland and Chicago, US-based Iterum Therapeutics have taken a hit on news that the firm's sulopenem did not achieve statistical non-inferiority relative to ertapenem in a trial in complicated urinary tract infection (cUTI).
The primary endpoint was overall clinical and microbiologic response on Day 21 in the micro-MITT population as evaluated using a 10% non-inferiority margin.
The randomised, multi-center, double-blind SURE 2 clinical trial enrolled 1,395 patients to measure the efficacy, tolerability, and safety of IV and oral sulopenem for the treatment of cUTI in adults.
Patients were randomised to receive either IV sulopenem once daily for at least five days followed by oral sulopenem twice daily to complete seven to ten days of treatment, or IV ertapenem once daily for a minimum of five days followed by either oral ciprofloxacin or, for quinolone resistant isolates, amoxicillin-clavulanate twice daily.
Responder rates for sulopenem were 67.8% and for ertapenem they were 73.9%, marking a difference of -6.1%. The difference in response rates was “driven almost entirely by higher rates of asymptomatic bacteriuria on sulopenem relative to ertapenem, only evident at the test of cure visit,” Iterum noted.
“We are very disappointed by the outcome in the cUTI study, although sulopenem was well tolerated and demonstrated a safety profile consistent with previous studies and the penem class in general,” said Corey Fishman, the firm's chief executive.
“Based on these trial results, Iterum is evaluating its corporate, strategic and financial alternatives with the goal of maximising value for its stakeholders while prudently managing its remaining resources.”
These alternatives, he said, could potentially include the licensing, sale or divestiture of the company’s assets or proprietary technologies, a sale of the company, a merger or other business combination, restructuring, dissolving and liquidating assets or seeking protection under bankruptcy laws.