8 January 2018 - - The FDA has granted US-based next-generation antibiotics developer VenatoRx Pharmaceuticals, Inc.'s lead antibiotic program, VNRX-5133, an injectable broad-spectrum β-lactamase inhibitor combined with a marketed β-lactam antibiotic, both the qualified infectious disease product (QIDP) and fast track designations, the company said.
The designations were granted for both complicated urinary tract infections and complicated intra-abdominal infections.
VNRX-5133 is a novel β-lactamase inhibitor with potent and selective direct inhibitory activity against both serine- and metallo-β-lactamases (i.e., Ambler Classes A, B, C, and D).
VNRX-5133, in combination with a marketed β-lactam antibiotic, has the potential to address the serious unmet medical need for a safe and effective therapy for treatment of infections caused by multi-drug resistant gram-negative bacteria, particularly carbapenem-resistant Enterobacteriaceae and multi-drug resistant Pseudomonas aeruginosa.
The VNRX-5133 program 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, and the Wellcome Trust.
VenatoRx is a private pharmaceutical company dedicated to the discovery and development of novel agents to address the threat of antibiotic bacteria resistance.