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Spero Therapeutics Announces New Strategic Direction Focusing on Advancing Promising Clinical-Stage Pipeline
Announces Immediate Cessation of Tebipenem HBr Commercialization Initiatives; Company to Shift Focus to Advancement of SPR720 and SPR206 Spero to Explore
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Announces Immediate Cessation of Tebipenem HBr Commercialization Initiatives; Company to Shift Focus to Advancement of SPR720 and SPR206 Spero to Explore Strategic Partnerships and Other Opportunities for Tebipenem HBr Conference Call and Live Webcast at 8:30 a.m. ET Today CAMBRIDGE, Mass., May 03, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, today announced that it will immediately defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting (LCM) with the U.S. Food and Drug Administration (FDA) regarding Spero’s New Drug Application (NDA) for tebipenem HBr. Although the review is still ongoing and the FDA has not yet made any final determination regarding approvability, the discussion suggested that the data package may be insufficient to support approval during this review cycle, as described below. In connection with this development, Spero announced that it is undertaking a reduction in its workforce by approximately 75% and a restructuring of its operations to reduce operating costs and reallocate resources towards the clinical development programs of SPR720 and SPR206, while continuing engagement with the FDA on the appropriate path forward for tebipenem HBr. Based on the anticipated cost-savings of this restructuring and other assumptions, Spero anticipates it will be able to fund its planned operating expenses and capital expenditure requirements pursuant to the priorities of its strategic refocusing through late 2023. “We are disappointed that the FDA has identified substantive review issues, and we strongly believe that tebipenem HBr would offer healthcare providers, payers and patients an important oral antibiotic alternative to IV treatment for cUTI for patients with limited oral treatment options,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “After careful consideration, and in light of the current FDA position, we have made the strategic decision to transition Spero’s focus and resources to supporting the clinical development of our promising clinical-stage pipeline, including SPR720, aimed at ...