Iterum Therapeutics (ITRM)

[swanlinbar]

ITRM >Iterum Announces First Patient Dosed in REASSURE, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
October 20 2022 - 07:30AM
GlobeNewswire Inc.
Alert
Print
Share On Facebook

Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company developing antibiotics to treat infections caused by multi-drug resistant pathogens, today announced that the first patient has been dosed in its Phase 3 clinical trial, known as REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales (REASSURE), comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).
“We are pleased to have successfully dosed our first patient in our Phase 3 clinical trial for oral sulopenem for the treatment of uUTI, which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA),” said Corey Fishman, Chief Executive Officer. “We anticipate completing the trial in the first half of 2024 with our existing cash resources. With positive results, we would resubmit our new drug application (NDA) to the FDA in the second half of 2024.”

About REASSURE

The REASSURE trial is designed as a non-inferiority trial comparing oral sulopenem and Augmentin® in the Augmentin susceptible population and is entitled “A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.” Patients will be randomized to receive either oral sulopenem twice daily for 5 days or Augmentin® twice daily for 5 days. The primary endpoint is the overall response (clinical and microbiologic combined response) at Day 12 of the trial. The trial is expected to enroll approximately 1,966 patients and is being conducted under a SPA agreement with the FDA.

Iterum expects to complete enrollment in the first half of 2024 and, if the Phase 3 clinical trial is successful, resubmit its NDA in the second half of 2024. If the resubmission addresses all deficiencies in the complete response letter received in July 2021 from the FDA, then the FDA’s review and action will occur six months from receipt of the resubmission.