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

Venatorx Pharmaceuticals today announced positive results from its pivotal Phase 3 study evaluating cefepime-taniborbactam, an investigational new drug, as a potential treatment for adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis.

Cefepime, a fourth-generation cephalosporin, is a widely used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, may offer a potential treatment option for patients with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative bacteria, most notably carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA). Many of these organisms are also multidrug-resistant (MDR), further limiting treatment options. Cefepime-taniborbactam has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the U.S. Food and Drug Administration (FDA).