Spero Therapeutics Tebipenem Pivoxil Hydrobromide Phase 3 Data Published in The New England Journal of Medicine
Excerpt from the Press Release:
CAMBRIDGE, Mass., April 06, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced publication in The New England Journal of Medicine (NEJM) of the results from the Phase 3 ADAPT-PO clinical trial for its investigational oral carbapenem antibiotic, tebipenem pivoxil hydrobromide (tebipenem HBr). The paper, titled “Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection,” is available online at the New England Journal of Medicine (NEJM).
“ADAPT-PO was a landmark trial that is the first Phase 3 head-to-head comparison of an all-oral versus all-IV treatment regimen in complicated urinary tract infection (cUTI) or acute pyelonephritis,” said Angela Talley, M.D., Senior Vice President, Clinical Development at Spero Therapeutics, and senior author of the NEJM paper.
“We are honored to have the results of our global Phase 3 trial published in The New England Journal of Medicine and we are grateful to the patients and investigators who participated in this trial,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics.
In September 2020, Spero Therapeutics announced the topline data from the Phase 3 ADAPT-PO clinical trial and, in October 2021, included the results from the completed trial in a New Drug Application (NDA) filed with the U.S. Food and Drug Administration (FDA). Earlier this year, Spero Therapeutics announced that the FDA accepted the NDA for substantive review and granted Priority Review designation. The NDA, which is currently under FDA regulatory review, seeks approval for tebipenem pivoxil oral tablets (tebipenem HBr) for the treatment of cUTI, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 27, 2022.
Click the button below to read the entire Press Release:
Discover What Sets TrialStat Apart From Ordinary EDC Platforms
Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?