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Spero Therapeutics Provides Tebipenem HBr Program Update Following Type A Meeting with the U.S. Food and Drug Administration
Alignment with the FDA on a regulatory path forward for the continued development of tebipenem Hbr FDA feedback indicates positive results from a single
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Alignment with the FDA on a regulatory path forward for the continued development of tebipenem Hbr FDA feedback indicates positive results from a single additional Phase 3 clinical trial in patients with complicated urinary tract infection (cUTI), with supportive confirmatory evidence of efficacy could support approval of tebipenem HBr Spero plans to advance tebipenem HBr’s clinical development and potential commercialization through external partnership CAMBRIDGE, Mass., Sept. 06, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) today 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. “We are pleased to have found common ground with the FDA on the regulatory path forward for tebipenem HBr,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “With this clarity, we are better positioned to advance the program as we work to establish and nurture external partnerships for further development. The pivotal Phase 3 trial is supported by an extensive clinical and nonclinical data package demonstrating the potential of tebipenem HBr to provide cUTI patients with an oral alternative to intravenous therapy; an option that we believe solidifies tebipenem HBr as a significant source of potential value that complements our lead SPR720, and partnership directed SPR206 programs.” 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...