The FDA has accepted Iterum Therapeutics’ oral sulopenem for priority review in the treatment of certain uncomplicated urinary tract infections. Securing the speedy review positions Iterum to learn whether the FDA will approve the drug by July 25.
Anti-infective specialist Iterum secured priority review status after submitting a data package built upon the findings of three phase 3 clinical trials. One of the clinical trials, SURE-2, missed its primary endpoint last year, sending shares in Iterum spiraling downward. However, with SURE-1 achieving its primary goal, Iterum has identified a population in which it thinks it can win approval.
The filing covers the use of oral sulopenem in the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen. Iterum tested the oral formulation in those patients in SURE-1.
The overall response rate in the oral sulopenem arm was 62.6%, versus 36% in the ciprofloxacin control arm. Other ways of measuring response and success generated somewhat different results, but the difference between oral sulopenem and ciprofloxacin remained statistically significant.
Iterum CEO Corey Fishman set out the importance of the results and the filing for approval.
“If approved, oral sulopenem would be the first penem available orally in the U.S. with the ability to treat multidrug resistant infections in the community. Specifically, this important antibiotic is one step closer to relieving the growing problem of quinolone resistance found in over six million uncomplicated urinary tract infections in the U.S. each year,” Fishman said in a statement.
The recent history of antibiotic development shows winning approval can mark the start of a fresh set of challenges. In 2019, Achaogen filed for bankruptcy less than one year after the FDA approved its new antibiotic plazomicin. Melinta Therapeutics filed for bankruptcy later that year before going on to emerge from the process with the support of Deerfield.