Iterum says Phase 3 trial of sulopenem did not meet primary endpoint
Iterum Therapeutics (ITRM) announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae 2 clinical trial in complicated urinary tract infection.
The primary U.S. Food and Drug Administration endpoint was overall clinical and microbiologic response on Day 21 in the micro-MITT population as evaluated using a 10% non-inferiority margin.
The randomized, 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 randomized to receive either IV sulopenem once daily for a minimum of 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 at the test of cure visit for sulopenem were 67.8% and for ertapenem were 73.9% with 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; the rates of patients receiving additional antibiotics or with residual cUTI symptoms was similar.
Clinical response at the test of cure in the Modified Intent to Treat patient population and Clinically Evaluable patient population sulopenem vs ertapenem: 0.4% was similar.
The outcome at other secondary endpoints was also similar, including the overall response at the end of therapy visit at Day 10.
Based on the trial results, Iterum Therapeutics is evaluating its corporate, strategic and financial alternatives with the goal of maximizing value for its stakeholders while prudently managing its remaining resources.
These alternatives 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, another strategic transaction involving the company, restructuring activities, winding down of operations, dissolving and liquidating assets or seeking protection under bankruptcy laws.
ITRM shares are down 54% to $1.95.
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