Business
Spero Therapeutics Announces Fourth Quarter and Full-Year 2020 Operating Results and Provides Business Update
Tebipenem HBr advancing towards NDA submission in the second half of 2021 Conference call and live webcast at 4:30 p.m. EST today CAMBRIDGE, Mass., March 11,
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Tebipenem HBr advancing towards NDA submission in the second half of 2021 Conference call and live webcast at 4:30 p.m. EST today CAMBRIDGE, Mass., March 11, 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 fourth quarter and full-year ended December 31, 2020 and provided a business update. “Over the last year we have made significant progress and completed critical milestones despite the industry-wide challenges brought about by the COVID-19 pandemic,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “Chief among these milestones was our announcement in September 2020 that the tebipenem HBr ADAPT-PO Phase 3 clinical trial in complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) met its primary endpoint. We look forward to another productive year in 2021, as we advance tebipenem HBr towards an NDA submission in the second half of 2021 and move closer to potentially addressing the unmet needs of the estimated 2.7 million cUTI and AP patients in the United States who may benefit from an oral treatment option that could prevent unnecessary hospitalizations.” Clinical Highlights and Upcoming Milestones Tebipenem HBr:In September 2020, Spero announced positive data from the ADAPT-PO Phase 3 clinical trial demonstrating that oral tebipenem HBr was statistically non-inferior to intravenous ertapenem in the treatment of patients with cUTI and patients with AP with respect to the primary endpoint. The ADAPT-PO clinical trial was the first trial to evaluate an all-oral regimen of tebipenem HBr head-to-head versus an all intravenous (IV) regimen of ertapenem for the treatment of adults with cUTI and AP. The top-line data as well as additional analyses from the trial were subsequently presented at IDWeek in October 2020. In January 2021, Spero announced that the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent No. 10,889,587, which covers a crystalline formulation of tebipenem HBr. This patent expires in February 2038. Tebipenem HBr has also been granted Qualified Infectious Disease Product (QIDP) and Fast Track de...