Iterum Therapeutics (ITRM) Provides Update from FDA Type A Meeting Regarding Oral Sulopenem

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, today announced that the Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) during the third quarter of 2021 to discuss the steps required for potential resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTI).

In July, the Company announced that it had received a Complete Response Letter (CRL) from the FDA requesting additional data to support approval of oral sulopenem for the treatment of adult women with a uUTI.

“We had a successful meeting with the FDA and have established various potential paths forward to address the request in the CRL for additional data in support of our NDA,” said Corey Fishman, Chief Executive Officer. “We are currently evaluating the optimal design for an additional Phase 3 uUTI study to be conducted prior to the potential resubmission of the NDA. We continue to believe in the ability of sulopenem to treat the growing problem of multi-drug resistant UTIs in the community.”

Iterum notes that cash, cash equivalents and short-term investments were $91.5 million at the end of the second quarter of 2021. Based on the current operating plan and subject to final determination of the design and planned conduct of additional clinical and potential nonclinical development for sulopenem, the Company believes that it is well positioned financially to fund its operations into the second half of 2023.

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