Pivotal Phase 3 clinical results for innovative antibiotic combination Actively plan to submit NDAs this year

Venatorx has announced positive results from a pivotal Phase 3 clinical trial of its innovative antibiotic combination, cefepime/taniborbactam, in adult patients with complicated urinary tract infections, including acute pyelonephritis

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.

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

This randomized, double-blind, active-controlled, global Phase 3 clinical trial was designed to evaluate the efficacy, safety and tolerability of cefepime/taniborbactam compared with meropenem in adult patients with complicated urinary tract infections

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

▲ Molecular formula of Taniborbactam (Image source: PubChem)

The incidence of adverse events (TEAEs) after treatment with cefepime/taniborbactam and the active control group were 35.

"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.

References:

[1] Venatorx Pharmaceuticals Announces Positive Results for Phase 3 Clinical Trial (CERTAIN-1) of Cefepime-Taniborbactam for Treatment of cUTI.