Business
Spero Therapeutics Announces Third Quarter 2021 Operating Results and Provides Business Update
Submitted NDA to U.S. FDA for tebipenem HBr for the treatment of complicated urinary tract infections, including pyelonephritis Entered into a non-dilutive
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Submitted NDA to U.S. FDA for tebipenem HBr for the treatment of complicated urinary tract infections, including pyelonephritis Entered into a non-dilutive revenue interest financing agreement with HealthCare Royalty Partners® for up to $125 million Conference call and live webcast at 4:30 p.m. ET today CAMBRIDGE, Mass., Nov. 10, 2021 (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 bacterial infections and rare diseases, today announced financial results for the third quarter ended September 30, 2021, and provided a business update. “During the quarter, we strengthened both our leadership team and financial position, while moving tebipenem HBr closer to a point where cUTI patients may soon have a solution to their existing unmet need,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “Chief among these accomplishments was our recent NDA submission for tebipenem HBr, which, if approved, would make it the first oral carbapenem antibiotic available for use in cUTI. We also entered into a revenue interest financing agreement with HealthCare Royalty Partners®, providing us with non-dilutive capital to support tebipenem HBr’s anticipated launch and the development of our early-stage programs.” Clinical Highlights and Upcoming Milestones Tebipenem HBr: In October 2021, Spero submitted a new drug application (NDA) to the United States Food and Drug Administration (FDA), seeking approval for tebipenem HBr tablets for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible microorganisms. The NDA submission includes previously communicated positive data from ADAPT-PO showing the Phase 3 trial met its primary endpoint by demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with acute pyelonephritis (AP). If approved, tebipenem HBr would be the only oral carbapenem antibiotic available for use in cUTI. The Company expects a commercial launch for tebipenem HBr in the second half of 2022, subject to its approval by the FDA. SPR720: In December 2020, SPR720 advanced into a Phase 2a ...