Shares in Iterum Therapeutics dropped as much as 57% on Monday after it announced that sulopenem, a novel penem anti-infective compound with oral and intravenous (IV) formulations, did not achieve the primary endpoint of a late-stage trial in complicated urinary tract infection (cUTI). The company indicated that based on the SURE 2 study results, it is exploring its options, which may include divesting assets, a restructuring, an outright sale of the company or possibly filing for bankruptcy, among other actions.
"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," noted CEO Corey Fishman.
The randomised SURE 2 trial enrolled 1395 patients with cUTI. Participants received either IV sulopenem once daily for at least five days, followed by an oral version of the drug 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. The primary endpoint was overall clinical and microbiologic response on day 21 in the micro-modified intent-to-treat (micro-MITT) population using a 10% non-inferiority margin.
Difference driven by asymptomatic bacteriuria rates
Iterum said responder rates at the test of cure visit for sulopenem were 67.8%, versus 73.9% for ertapenem. According to the company, "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." Meanwhile, it said "the rates of patients receiving additional antibiotics or with residual cUTI symptoms [were] similar." Iterum indicated that the outcome at other secondary endpoints was also similar, including the overall response at the end of therapy visit at day 10, with rates of 86.7% and 88.9%, respectively, for the sulopenem and ertapenem groups.
Given the results, Iterum said it is evaluating "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." However, it cautioned that its review may ultimately lead to no particular actions taken.
Second failure for sulopenem
Aside from cUTI, oral and IV sulopenem is also in late-stage testing for uncomplicated UTI in the SURE 1 trial, with results anticipated in the second quarter. The drug is also being assessed as a potential treatment for complicated intra-abdominal infections (cIAI) in the SURE 3 study, but in December, Iterum shares nearly halved when it said the trial had failed to achieve its primary endpoint.
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