Feb 02, 2023 / 07:30PM GMT
Judith Matthews - Iterum Therapeutics plc - CFO
Hi. I'm Judy Matthews, co-founder and CFO of Iterum Therapeutics. Thank you for your time today.
I will jump right in with our lead product, sulopenem. Sulopenem is a penem antibiotic that has both IV and oral formulations. We are currently focused on the development of oral sulopenem, which we've combined with probenecid and a bilayer tablet. Oral sulopenem is active against common urinary and GI tract bacteria, which is why we are developing it to treat uncomplicated urinary tract infections or uUTI.
In addition to uUTI, there is potential to expand the sulopenem label over time in areas such as community acquired bacterial pneumonia and gonorrhea, among other indications. We are currently conducting a confirmatory Phase 3 clinical trial in uUTI under a special protocol assessment agreement or SPA with the FDA. It is a non-inferiority study of oral sulopenem compared to Augmentin, amoxicillin/clavulanate, in the Augmentin susceptible population, referred to as the REASSURE trial.
We began enrollment in October 2022 and currently
Iterum Therapeutics PLC at SRAX Sequire Biotechnology Conference (Virtual) Transcript
Feb 07, 2024
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