Iterum Therapeutics Plc (ITRM) has released an update.
The Company announced successful Phase 3 trial results for Oral Sulopenem in treating uncomplicated urinary tract infections (uUTIs), showing it was non-inferior and statistically superior to Augmentin®. The trial, conducted under an FDA special protocol assessment, showed a higher overall success rate for Oral Sulopenem with no serious adverse events reported. Furthermore, consistent results were observed across all key secondary efficacy endpoints. With these positive outcomes, the Company plans to resubmit its New Drug Application to the FDA in Q2 2024 and anticipates FDA action by Q4 2024, while also exploring strategic options to maximize stakeholder value for its rights to sulopenem.
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For a comprehensive understanding of the announcement, you can read the full document here.
