Spero Therapeutics IncSPROreceived minutes from a recent Type A meeting with the FDA, discussing steps required to resubmit the marketing application for tebipenem HBr for complicated urinary tract infection (cUTI).
During the Type A meeting, the FDA indicated that positive results from an additional Phase 3 trial supported by confirmatory nonclinical efficacy evidence could be sufficient to support the approval of tebipenem HBr for cUTI, including pyelonephritis for a limited use indication.
Spero and the FDA also aligned the key components of the proposed pivotal Phase 3 trial design, which may be the subject of a Special Protocol Assessment request, to be confirmed once the clinical protocol is finalized.
Spero received a Complete Response Letter from the FDA in June 2022, citing data from Spero’s initial Phase 3 cUTI clinical trial, ADAPT-PO, that were insufficient to support approval.
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