Spero Therapeutics, Inc. provided an update on its tebipenem HBr program following the receipt of minutes from a recent Type A meeting with the U.S. Food and Drug Administration (FDA), discussing steps required for resubmission of the New Drug Application (NDA) for tebipenem HBr for the treatment of complicated urinary tract infection (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 nonclinical 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. Spero and the FDA also achieved alignment on key components of the proposed pivotal Phase 3 trial design which may be the subject of a Special Protocol Assessment (SPA) request, to be confirmed once the clinical protocol is finalized.

As previously reported, Spero received a Complete Response Letter (CRL) from the FDA in June 2022 for a prior NDA seeking approval for tebipenem HBr for the treatment of adult patients with certain bacterial microorganisms that cause cUTI, including pyelonephritis. In the CRL, the FDA concluded that data from Spero's prior Phase 3 cUTI clinical trial, ADAPT-PO, were insufficient to support approval during the prior review cycle. Spero plans to advance tebipenem HBr's clinical development and potential commercialization through external partnership, and if approved, tebipenem HBr would be the first oral carbapenem antibiotic to receive marketing approval in the United States.

Tebipenem HBr Research Support Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority.