Spero Gets Special Protocol Assessment Agreement with FDA for Phase 3 Trial of UTI Therapy

 Phase3PIVOT-POtrialisexpectedtobeginwithFirstPatient,FirstVisitin4Q2023

Spero to receive $30 million development milestone payment from GSK

Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in areas of high unmet need involving rare diseases and multi-drug resistant (MDR) bacterial infections, announced today that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).

https://www.biospace.com/article/releases/spero-therapeutics-announces-special-protocol-assessment-agreement-with-fda-for-phase-3-pivot-po-trial-of-tebipenem-hbr/