Iterum's oral sulopenem meets Phase 3 uUTI endpoint, shows superiority over Augmentin

Iterum Therapeutics plc

Primary endpoint met: overall success 61.7% (sulopenem) vs 55.0% (Augmentin); 95% CI lower bound >0 showing statistical superiority.
No serious adverse events on sulopenem; discontinuations <1% in both arms; safety consistent with prior trials.
NDA resubmission planned for Q2 2024; FDA action expected in Q4 2024 if deficiencies addressed.
Company initiating strategic process to sell, license, or dispose of sulopenem rights to maximize value.

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