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Spero Therapeutics Completes Patient Enrollment in Pivotal Phase 3 Clinical Trial (ADAPT-PO) of Oral Tebipenem HBr versus Intravenous Ertapenem for the Treatment of Complicated Urinary Tract Infection
ADAPT-PO topline results expected in the third quarter of 2020 CAMBRIDGE, Mass., May 05, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"ADAPT-PO topline results expected in the third quarter of 2020\nCAMBRIDGE, Mass., May 05, 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 the completion of patient enrollment in its Phase 3 clinical trial, ADAPT-PO, of tebipenem HBr for the treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). \n “Completing enrollment of ADAPT-PO is a significant milestone in the development of tebipenem HBr,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “Resistance to current orally available antibiotic therapies impacts millions of people in the United States each year and leads to more than two million avoidable hospitalizations for complicated urinary tract infections. The need for new oral therapies to keep patients out of the hospital has never been greater. We are committed to providing patients with cUTI or AP, who otherwise do not require hospitalization, with an alternative and allowing them to once again use an oral agent and remain at home. With enrollment now complete, we are on track to report topline data in the third quarter of 2020, consistent with our prior guidance.” ADAPT-PO enrolled over 1,370 eligible subjects in a global study designed as a double-blind, double-dummy clinical trial to compare an all-oral regimen of tebipenem HBr dosed as 600 mg TID with a standard-of-care intravenous (IV) antibiotic, ertapenem, in patients with cUTI and AP, randomized 1:1 in each arm. With enrollment complete, the final group of patients in the trial will complete their treatment course and final safety follow-up visit. Spero anticipates reporting topline results from the ADAPT-PO clinical trial in the third quarter of 2020. About Tebipenem HBrTebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero’s novel investigational oral formulation of tebipenem pivoxil, a carbapenem-class antibiotic marketed by Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis. Carbapenems are an important class of antibiotics because they have been...