Business
Spero Therapeutics Announces Fourth Quarter and Full-Year 2019 Operating Results and Provides Pipeline Update
2020 catalysts include tebipenem HBr pivotal Phase 3 top-line cUTI data in 3Q20 and SPR720 Phase 2a NTM trial initiation in 2H20 CAMBRIDGE, Mass., March 16,
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"2020 catalysts include tebipenem HBr pivotal Phase 3 top-line cUTI data in 3Q20 and SPR720 Phase 2a NTM trial initiation in 2H20\nCAMBRIDGE, Mass., March 16, 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 fourth quarter and full-year ended December 31, 2019 and provided a pipeline update.\n “In 2019 and continuing into 2020, we have made significant clinical progress with positive clinical data reported for all of our pipeline programs, all of which are designed to address serious unmet needs and to treat multi-drug resistant infections,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “We have a solid cash position heading into 2020 bolstered by proceeds from our $30 million rights offering that closed in early March 2020, and we look forward to an eventful 2020 that includes top-line data from our pivotal Phase 3 clinical trial of tebipenem HBr in complicated urinary tract infections (cUTI) expected in the third quarter of 2020.” 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 for use in adults to treat MDR Gram-negative infections. Spero’s pivotal Phase 3 clinical trial of tebipenem HBr for the treatment of cUTI, ADAPT-PO, is currently enrolling patients. The ADAPT-PO trial compares an all oral regimen of tebipenem HBr with an existing standard of care intravenous (IV) antibiotic, ertapenem, in approximately 1,200 patients with cUTI or acute pyelonephritis, randomized 1:1 in each arm. In October 2019, an independent review committee analyzed interim pharmacokinetic (PK) data from the first 33 patients dosed with tebipenem HBr and recommended the continuation of the trial using the protocol-defined dose without modification. Spero continues to expect to report top-line data from the ADAPT-PO trial in the third quarter of 2020. To support continued clinical development of tebipenem HBr, in February 2020 the Biomedical Advanced Research and Development Authority (BARDA) exercised a $15.9 million opt...