- Iterum Therapeutics plc (NASDAQ:ITRM) has agreed with the FDA under the special protocol assessment (SPA) process on the design, endpoints, and statistical analysis of a Phase 3 trial for oral sulopenem etzadroxil-probenecid for uncomplicated urinary tract infections.
- The pivotal study under the SPA agreement is designed as a non-inferiority trial comparing oral sulopenem and Augmentin (amoxicillin/clavulanate).
- Related: Iterum Expects To Start Additional Sulopenem Trial In Urinary Tract Infections In 2H22.
- Patients will be randomized to receive either oral sulopenem twice daily for five days or Augmentin twice daily for five days.
- The primary endpoint is the overall 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.
- The Company has already commenced study start-up activities to enable timely initiation and recruitment.
- Price Action: ITRM shares are up 62.10% at $0.39 during the market session on the last check Monday.
Iterum Therapeutics Shares Are Surging – Read Why
Iterum Therapeutics plc (NASDAQ:ITRM) has agreed with the FDA under the special protocol assessment (SPA) process on the design, endpoints, and…
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