Iterum announces completion of enrollment in it REASSURE Phase 3 trial

Iterum Therapeutics announced the completion of patient enrollment in its REASSURE clinical trial comparing oral sulopenem to oral Augmentin in adult women with uncomplicated urinary tract infections, uUTI. “We are extremely pleased to have completed enrollment in our REASSURE trial well ahead of schedule. We now expect topline results early in the first quarter of 2024, and subject to our analysis of the data, plan to resubmit our NDA to the FDA in the second quarter of 2024,” said Corey Fishman, Chief Executive Officer. “This significant milestone represents another exciting step forward in the development of oral sulopenem and potentially bringing to market the first antibiotic approved for the treatment of uUTIs in over 25 years, as well as the first oral penem, in the U.S.” Iterum expects to report topline data early in the first quarter of 2024 and, subject to its analysis of the data, to resubmit its New Drug Application for oral sulopenem for the treatment of uUTIs to the U.S. Food and Drug Administration in the second quarter of 2024.