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Tebipenem Pivoxil Hydrobromide is Non-inferior to IV Ertapenem

Results from the Pivotal ADAPT-PO study were reported.

Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an oral therapy that is converted into plasma to the carbapenem, tebipenem. The therapy has shown in vitro activity against select multidrug-resistant Gram-negative pathogens, including fluoroquinolone-resistant and extended-spectrum ß-lactamase (ESBL)-producing Enterobacterales.

TBP-PI-HBr is being developed in the United States as the first oral carbapenem for treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).

Investigators wanted to examine the oral administration of Tebipenem Pivoxil Hydrobromide to find out if was non-inferior to IV Ertapenem in cUTI and AP in the ADAPT-PO trial.

This study was a global, double-blind, phase 3 study. According to the investigators, “the primary endpoint was overall response (composite clinical cure and microbiologic eradication) at the test-of-cure (TOC) visit (Day 19 ± 2) in the micro-ITT population. Patients (N=1372) were randomized 1:1 to receive TBP-PI-HBr 600 mg PO q8h plus placebo IV q24h or ertapenem 1 g IV q24h plus oral placebo q8h for 7-10 days (or up to 14 days in patients with bacteremia).”

“Oral TBP-PI-HBr met the primary objective of non-inferiority compared with IV ertapenem with an overall response rate of 58.8% (264/449) vs. 61.6% (258/419), respectively (treatment difference -3.3%; 95% CI: -9.7, 3.2; -12.5% NI margin),” investigators reported about the results. “Clinical cure rates at TOC were > 93% in both treatment groups. Microbiological response rates for target uropathogens were comparable across treatment groups.”

“Results from this pivotal Phase 3 study provide the first head-to-head demonstration of non-inferiority of an oral (TBP-PI-HBr) antibacterial agent to an IV (ertapenem) agent in patients with cUTI and AP, with a comparable tolerability profile,” investigators concluded.

The study, “Oral Tebipenem Pivoxil Hydrobromide is Non-inferior to IV Ertapenem in Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)–Results from the Pivotal ADAPT-PO Study,” was presented virtually at ID Week 2020.