Spero Therapeutics Discusses Resubmission Of NDA For Tebipenem HBr After Discussion With FDA

(RTTNews) - Spero Therapeutics, Inc. (SPRO) Tuesday announced that after the recent Type A meeting with FDA, the company is discussing resubmission of the New Drug Application or NDA for tebipenem HBr. The investigational drug is being developed for the treatment of complicated urinary tract infections cUTI, including pyelonephritis.

During the Type A meeting, the FDA indicated that positive results from a single additional Phase 3 clinical trial supported by confirmatory non-clinical evidence of efficacy could be sufficient to support the approval of tebipenem HBr for the treatment of cUTI, including pyelonephritis for a limited use indication.

Earlier, the clinical-stage biopharmaceutical company received a Complete Response Letter from the FDA in June 2022 for a prior NDA seeking approval for tebipenem HBr. The FDA has concluded that data from Spero's prior Phase 3 cUTI clinical trial, ADAPT-PO, were insufficient to support approval during the prior review cycle.