The pivotal Phase 3 clinical results of the innovative antibiotic combination of Express Express are positive, and the new drug application is planned to be submitted this year

▎WuXi AppTec Content Team Editor A few days ago, Venatorx announced that its innovative antibiotic combination, cefepime/taniborbactam, is in a pivotal Phase 3 clinical trial in adult patients with complicated urinary tract infections, including acute pyelonephritis.
Get positive results
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The cefepime/taniborbactam combination met the non-inferiority endpoint and demonstrated statistical superiority compared to the control antibiotic
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Cefepime is a fourth-generation cephalosporin, a widely used β-lactam (BL) antibiotic, which has been used for more than 20 years in the fight against sensitive Gram-negative and Gram-positive bacteria.
Safety and efficacy have been proven
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Taniborbactam, a beta-lactamase inhibitor (BLI), in combination with cefepime may provide a potential treatment option for patients with severe bacterial infections caused by refractory, drug-resistant Gram-negative bacteria
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Cefepime/taniborbactam has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the US FDA
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It is worth mentioning that China's Genting Xinyao has reached a research and development cooperation with Venatorx to jointly develop cefepime/taniborbactam
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Complicated urinary tract infection (including acute pyelonephritis) is a urinary tract infection that ascends from the bladder and is accompanied by local or systemic symptoms such as fever, chills, malaise, lumbar and flank pain, back pain and/or costal angle pain or tenderness and symptoms, predisposing factors are usually functional or anatomical abnormalities of the urinary system or the need for catheterization
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Bacteremia caused by complicated urinary tract infections can lead to major comorbidities and death
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This randomized, double-blind, active-controlled, global Phase 3 trial was designed to evaluate the efficacy, safety and tolerability of cefepime/taniborbactam compared with meropenem in adults with complicated urinary tract infections
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The results of the trial showed that cefepime/taniborbactam met the primary endpoint of the trial and achieved statistical non-inferiority criteria compared to the active control group
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The composite endpoint of clinical and microbiological response (bacterial eradication) was achieved in 70.
0% of patients in the cefepime/taniborbactam group compared to 58% in the active control group
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The prespecified superiority analysis after meeting the primary endpoint of noninferiority showed statistical superiority of the cefepime/taniborbactam combination
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▲ Molecular formula of Taniborbactam (Image source: PubChem) The incidence of adverse events (TEAE) after treatment with cefepime/taniborbactam and the active control group was 35.
5% and 29.
0%, respectively
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Serious TEAEs occurred in 2.
0% and 1.
8% of patients with cefepime/taniborbactam and the active control group, respectively
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There was one death in the cefepime/taniborbactam group unrelated to the investigational therapy as assessed by the investigator
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Full study results will be presented at an upcoming scientific meeting
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"These data suggest that cefepime/taniborbactam may represent a significant improvement over standard of care and could support global efforts to combat antibiotic-resistant infections," said Dr.
Christopher J.
Burns, President and CEO of Venatorx
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If approved by the US FDA, it may provide a new treatment option for patients with infections caused by highly resistant bacteria
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We plan to submit a new drug for cefepime/taniborbactam to the US FDA for the treatment of adult patients with complicated urinary tract infections later this year .
Apply
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"Reference: [1] Venatorx Pharmaceuticals Announces Positive Results for Phase 3 Clinical Trial (CERTAIN-1) of Cefepime-Taniborbactam for Treatment of cUTI.
Retrieved March 11, 2022, from https:// home/20220310005341/enDisclaimer: The WuXi AppTec content team focuses on introducing the progress of global biomedical health research
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This article is for information exchange purposes only, and the views in this article do not represent WuXi AppTec's position, nor do it mean that WuXi AppTec supports or opposes the views in the article
This
article is not a treatment plan recommendation
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If you need treatment plan guidance, please go to a regular hospital for treatment
.