Iterum Therapeutics plc (Nasdaq: ITRM) shares surged 39.31% to $0.9055 in the after-hours session, after a drug company involved in developing oral and IV antibiotics of the next generation to treat infections caused by multidrug-resistant pathogens plunged -1.52% in yesterday’s normal trading session.
The company has applied its New Drug Proposal (NDA) to the U.S. Food and Drug Administration for sulopenem etzadroxil/probenecid in patients with a quinolone non-susceptible pathogen, to treat uncomplicated urinary tract infections (uUTIs).
Corey Fishman, Chief Executive Officer, said The submission of the oral sulopenem NDA filing is an important step forward in bringing new antibiotics to patients to help address the antibiotic resistance challenge.” Oral sulopenem, if licensed, will provide doctors and patients the ability to benefit from the proven effectiveness and protection of penem antibiotics found only in IV formulations to date in the U.S..’ We are now one step closer to fulfilling the target of getting this desperately needed drug to the U.S. every year for more than six million patients with Cipro-resistant UTIs.
The NDA request contains evidence from the phase 3 clinical trials of SURE-1, SURE-2, and SURE-3, in which oral sulopenem was well received with no major adverse drug-related events. The SURE-1 clinical trial (uUTIs) found that oral sulopenem was statistically superior to the commonly used comparator, ciprofloxacin, for the primary clinical and microbiological reaction efficacy endpoint the test-of-cure visit in patients with a non-susceptible quinolone pathogen.