Spero Therapeutics: FDA agrees single additional Phase 3 trial could support approval of tebipenem HBr for cUTI

Spero Therapeutics, Inc.

FDA indicated positive results from one additional Phase 3 trial, plus confirmatory nonclinical evidence, could support approval.
Spero plans to advance tebipenem HBr development and potential commercialization through external partnership.
Type A meeting follows June 2022 CRL; FDA aligned on key components for pivotal trial design, with possible SPA.
If approved, tebipenem HBr would be the first oral carbapenem antibiotic in the U.S.

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