Business
Spero Therapeutics Announces First Quarter 2020 Operating Results and Provides Business Update
Tebipenem HBr Phase 3 trial enrollment complete with top-line data expected in the third quarter of 2020 SPR720 Phase 2a NTM trial initiation planned for the
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Tebipenem HBr Phase 3 trial enrollment complete with top-line data expected in the third quarter of 2020\n SPR720 Phase 2a NTM trial initiation planned for the second half of 2020 Conference call and live webcast at 10:00 a.m. EDT today CAMBRIDGE, Mass., May 08, 2020 (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 first quarter ended March 31, 2020 and provided a business update. “We have made significant progress to date in 2020 in advancing our pipeline of drug candidates for serious unmet needs and multi-drug resistant infections,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “We completed enrollment in our Phase 3 trial, ADAPT-PO, comparing oral tebipenem HBr to IV ertapenem, and look forward to reporting data from the trial in the third quarter of 2020. We believe that positive results and subsequent approval of tebipenem HBr would provide great benefits to patients, hospitals and payors, as it would enable the treatment of complicated urinary tract infections with an oral agent outside of the hospital, an option that is not currently available given the lack of approved oral treatments.” Recent Clinical Highlights and Upcoming Milestones Tebipenem HBr:Spero’s lead product candidate, tebipenem HBr, has the potential to be the first oral carbapenem antibiotic approved to treat MDR Gram-negative infections. The pivotal Phase 3 clinical trial of tebipenem HBr for the treatment of complicated urinary tract infection (cUTI), ADAPT-PO, completed enrollment of approximately 1,370 patients and Spero continues to expect to report top-line data in the third quarter of 2020. The ADAPT-PO trial is comparing an all oral regimen of tebipenem HBr with an existing standard of care intravenous (IV) antibiotic treatment, ertapenem, in patients with cUTI or acute pyelonephritis, randomized 1:1 in each arm. In October 2019, pharmacokinetic (PK) data from the first 33 patients dosed with tebipenem HBr in the Phase 3 trial were analyzed by an independent review committee which recommended that the trial continue without modifications to the protocol...