- The shares of clinical-stage pharma Iterum Therapeutics ( NASDAQ: ITRM ) jumped ~64% in the morning hours Monday after the company announced an agreement with the FDA over the design of a Phase 3 trial for oral sulopenem, a candidate for urinary tract infections (UTI).
- Under the special protocol assessment, Iterum ( ITRM ) and the agency on the design, endpoints and statistical analysis of a Phase 3 clinical trial designed to evaluate sulopenem in uncomplicated UTI, the company said.
- “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,” remarked Chief Executive Corey Fishman.
- Iterum ( ITRM ) expects to run the study as a non-inferiority trial, comparing sulopenem, also known as etzadroxil-probenecid, and Augmentin (amoxicillin/clavulanate). The trial involving nearly 1,966 patients is expected to start in 4Q 2022.
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Iterum jumps 64% as FDA agrees to Phase 3 trial for UTI candidate