Sulopenem demonstrates superiority in treatment of patients with quinolone resistant pathogens
Company to discuss NDA filing with FDA
DUBLIN, Ireland and CHICAGO, June 29, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (NASDAQ:ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced topline results from its Sulopenem forResistantEnterobacteriaceae (SURE) 1 clinical trial for the treatment of Uncomplicated Urinary Tract Infections (uUTI). Sulopenem is a novel anti-infective compound that, if approved, would be the first penem antibiotic with an oral formulation indicated for treatment of uUTI.
In SURE1, there were two independent primary endpoints, with achievement of either of those endpoints expected to provide a potential path to marketing approval based on previous discussions with the U.S. Food and Drug Administration (FDA). In the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing substantial evidence of a treatment effect in patients with uUTI. With a p-value of <0.001, this result was highly statistically significant. In the second population of patients with organisms susceptible to quinolones, sulopenem was not non-inferior to ciprofloxacin and did not achieve the related primary endpoint, with the difference in outcomes driven by the rate of asymptomatic bacteriuria post treatment. In SURE1, sulopenem was well tolerated with a favorable safety profile, consistent with the SURE2 and SURE3 trials.
"We are extremely pleased to have a potential path to approval for sulopenem in uUTI. Approximately 5-6 million urinary tract infections in the U.S. every year are caused by quinolone resistant pathogens. If approved, sulopenem would provide a treatment option for women with infections due to these resistant pathogens," said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. "Sulopenem is the first new oral antibiotic to demonstrate success in treating uUTIs in a phase 3 trial in over twenty years." Mr. Fishman continued, "We anticipate a pre-NDA meeting with the FDA in the third quarter of 2020 to discuss a path forward."
Michael Dunne, M.D., Chief Scientific Officer of Iterum Therapeutics, stated, "Superiority trials to define the effectiveness of novel antibacterial agents are rarely performed but remain the ultimate test for defining the value of a new agent in an area of high unmet medical need. Sulopenem has demonstrated efficacy in the treatment of UTI due to a quinolone resistant organism, a scenario found in almost 30% of all urinary tract infections in women in the United States today."
The randomized, multi-center, double-blind SURE1 clinical trial enrolled 1,670 patients to measure efficacy, tolerability, and safety of oral sulopenem/probenecid for the treatment of uUTI in adult women. Patients were randomized to receive either oral sulopenem/probenecid twice daily for five days of treatment, or oral ciprofloxacin twice daily for three days of treatment.The End of Treatment (EOT) visit occurred on Day 5 and the Test of Cure Visit (TOC) at Day 12. Two independent populations were prespecified and tested for an overall response of success at the TOC: a quinolone resistant population being assessed for superiority, defined as a p value <0.05, and a quinolone susceptible population being tested for non-inferiority, based on the lower limit of the 95% confidence interval (CI) for the difference in the microbiologic-modified intent to treat population being greater than -10%. A prespecified analysis of the outcome in both susceptible and non-susceptible patients combined was also performed to describe the overall results of treatment of uUTI with sulopenem relative to ciprofloxacin. The following table sets forth the topline results from the trial.