April 07, 2022
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Source / Disclosure
Disclosure: Tally is employed by Spero Therapeutics. Please refer to the study for the relevant financial disclosures of all other authors.
Oral tebipenem is non-inferior to pivoxil hydrobromide IV ertapenem for the treatment of uncomplicated UTIs and acute pyelonephritis, according to the results of a phase 3 trial published in May. New England Journal of Medicine,
Angela K. Tally, MD, Senior Vice President of Clinical Development at Sphero Therapeutics and clinical lead for the Tebipenum Hydrobromide Program, uncomplicated UTIs (CUTIs) – including acute pyelonephritis ( Associated Press) – affect approximately 3 million people each year in the United States and are “a substantial clinical —and presents an economic burden on the health care system due to repeated hospitalizations and the need for IV therapy.
“No new oral antibiotic options have emerged to treat these conditions in more than 25 years,” Tally told Helio. “As antimicrobial resistance is increasing worldwide, especially due to complex UTIs or APs among common Gram-negative pathogens, there is an urgent need for new, effective oral treatment options for this disease.”
Tally and colleagues assessed the efficacy and safety of orally administered tebipenem pivoxil hydrobromide as an alternative to IV ertapenem among patients hospitalized with cUTI or Associated Press in phase 3, doubled at 95 sites in Europe, South Africa. -Blind, double-dummy test. United States of america.
They randomly assigned adult patients to receive either 600 mg oral tebipenem pivoxil hydrobromide every 8 hours or 1 gram IV ertapenem every 24 hours in a 1:1 ratio for 7 to 10 days. Bacterial patients received treatment for 14 days. The primary efficacy endpoint was overall response at a trial-to-treat visit in the microbiological intent-to-treat population.
Overall, the study enrolled 1,372 hospitalized patients, with 50.8% CUTI and 49.2% Associated Press in 868 microbiological intent-to-treat populations.
According to Tally and colleagues, there was an overall response in 58.8% of patients in the tebipenem pivoxil hydrobromide arm, compared to 61.6% of patients who received ertapenem, with a weighted difference of -3.3 percentage points (95% CI, 9.7 to 3.2). ,
At the trial-to-treat visit, they saw a clinical cure in 93.1% of patients in the microbiological intent-to-treat population who received tebipenem pivoxil hydrobromide and 93.6% of patients who received ertapenem, with a -0.6 percent There was a weighted difference. score (95% CI, 4.0–2.8).
He said that most of the patients with microbiological response failure during the trial were asymptomatic and had recurrent bacteriuria. They also noted that the safety profiles were similar between regimens.
Tally said, “The data from this landmark study suggest that tebipenem pivoxil hydrobromide, an investigational drug, may potentially address the current unmet need for new oral treatment options for suitable patients with CUTI or Associated Press. ” “In the absence of other effective oral agents, [it] may provide an alternative for the treatment of cUTIs or APs due to certain antibiotic-resistant uropathogens.”