Cefepime-Taniborbactam

Venatorx Pharmaceuticals’ most advanced development-stage product is taniborbactam (formerly VNRX-5133), an injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro activity against both serine- and metallo-beta-lactamases (MBLs), including the following enzymes:

  • extended spectrum beta-lactamase (ESBL);
  • Oxacillinase (OXA);
  • Klebsiella pneumoniae carbapenemase (KPC);
  • New Delhi metallo-beta-lactamase (NDM); and
  • Verona integron-encoded metallo-beta-lactamase (VIM).

Venatorx believe that taniborbactam, in a fixed combination with the fourth generation cephalosporin, cefepime, has the potential to provide a valuable broad-spectrum treatment option to meet unmet medical needs in patients with infections due to carbapenem-resistant pathogens including carbapenem-resistant Enterobacteriaceae (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA), suspected polymicrobial infections caused by both gram-negative and gram-positive susceptible pathogens, and engineerable bioterror pathogens such as Burkholderia spp.

Venatorx initiated enrollment in its Phase 3 trial of cefepime-taniborbactam in patients with complicated urinary tract infections (cUTIs) in August 2019, expects to enroll 582 patients for this study, with top-line results expected by the end of 2020.

This Phase 3 clinical trial (ClinicalTrials.gov – NCT03840148) is a global randomized, double-blind, active controlled, non-inferiority study evaluating the efficacy, safety, and tolerability of cefepime-taniborbactam in adults with cUTI, including acute pyelonephritis. The trial will assess the safety and efficacy of cefepime-taniborbactam as compared with that of meropenem using clinical cure and microbiological eradication as the primary composite efficacy endpoint.

This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201300019C, The Wellcome Trust under Award No. 360G-Wellcome-101999/Z/13/Z, and the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services under Contract No. HHSO100201900007C.