A New Drug Application has been submitted to the Food and Drug Administration (FDA) for tebipenem HBr (tebipenem pivoxil hydrobromide) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible microorganisms.
Tebipenem HBr is an investigational oral antibiotic in the carbapenem class. The submission is supported by data from the multicenter, randomized, double-blind, double-dummy phase 3 ADAPT-PO trial (ClinicalTrials.gov Identifier: NCT03788967), which evaluated the efficacy and safety of tebipenem HBr in 868 adults with cUTI or acute pyelonephritis.
Patients were randomly assigned 1:1 to receive either tebipenem HBr 600mg orally 3 times a day or ertapenem 1g via intravenous infusion once daily for 7 to 10 days. The primary endpoint was overall response (combined clinical cure plus microbiological eradication) at test-of-cure visit in the microbiological-intent-to-treat population.
Results showed treatment with tebipenem HBr was statistically noninferior to ertapenem with respect to overall response at the test-of-cure visit in the microbiological-intent-to-treat population. Overall response rates were 58.8% (n=264/449) for tebipenem HBr compared with 61.6% (n=258/419) for ertapenem (treatment difference, -3.3%; 95% CI, -9.7, 3.2). Both treatment arms had high clinical cure rates at test-of-cure visit (less than 93%).
“With the submission of this NDA, we have taken a major step towards potentially providing a substantial number of appropriate cUTI patients with an oral treatment option that could replace historical use of intravenous therapy,” said Ankit Mahadevia, MD, CEO of Spero Therapeutics. “We look forward to working with the FDA during the NDA review process as we prepare for tebipenem HBr’s anticipated launch in the second half of 2022.”
- Spero Therapeutics submits New Drug Application to US FDA for tebipenem HBr for the treatment of complicated urinary tract infections including pyelonephritis. News release. Spero Therapeutics, Inc. Accessed October 28, 2021. https://www.globenewswire.com/news-release/2021/10/28/2322733/0/en/Spero-Therapeutics-Submits-New-Drug-Application-to-U-S-FDA-for-Tebipenem-HBr-for-the-Treatment-of-Complicated-Urinary-Tract-Infections-including-Pyelonephritis.html.
- Spero Therapeutics announces positive topline results from its phase 3 ADAPT-PO clinical trial of oral tebipenem HBr in complicated urinary tract infection and acute pyelonephritis. News release. Spero Therapeutics, Inc. September 8, 2020. Accessed October 28, 2021. https://investors.sperotherapeutics.com/news-releases/news-release-details/spero-therapeutics-announces-positive-topline-results-its-phase.