Iterum Therapeutics (ITRM)

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$ITRM Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA
July 11 2022 - 07:30AM
GlobeNewswire Inc.

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Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, announced today that it has reached an agreement with the U.S. Food and Drug Administration (“FDA”) under the special protocol assessment (“SPA”) process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated urinary tract infections (“uUTI”). The SPA agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of the Company’s new drug application (“NDA") for oral sulopenem.
“We are pleased to have concluded discussions with the FDA and reached agreement on key elements of the trial design to support the potential resubmission of the NDA for oral sulopenem for uUTI under the SPA process,” said Corey Fishman, Chief Executive Officer. “The SPA underscores our alignment with the FDA on important regulatory, clinical and scientific requirements for our planned Phase 3 trial in uUTI and reflects our ongoing commitment to bring this valuable therapy to market. We are excited about this important milestone and are looking forward to starting recruitment for this trial as soon as possible.”

The pivotal study to be conducted pursuant to the SPA agreement is designed as a non-inferiority trial comparing oral sulopenem and Augmentin® (amoxicillin/clavulanate) 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 study. The study is expected to enroll approximately 1,966 patients and is anticipated to start enrolling in the fourth quarter of 2022. Study start-up activities have already been commenced by the Company to enable timely initiation and recruitment.