Posted by Michael Wonder on 04 Jan 2018
VenatoRx Pharmaceuticals receives FDA’s QIDP and fast track designations for development of its lead antibiotic program
3 January 2018 - VenatoRx Pharmaceuticals, a private clinical-stage pharmaceutical company, announced today that the FDA has granted the company's lead antibiotic program, VNRX-5133, an injectable broad-spectrum beta-lactamase inhibitor combined with a marketed beta-lactam antibiotic, both the Qualified Infectious Disease Product (QIDP) and Fast Track designations. The designations were granted for both complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
VNRX-5133 is a novel beta-lactamase inhibitor with potent and selective direct inhibitory activity against both serine- and metallo-beta-lactamases (i.e., Ambler Classes A, B, C, and D). VNRX 5133, in combination with a marketed beta-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 (MDR) gram-negative bacteria, particularly carbapenem-resistant Enterobacteriaceae (CRE) and multi-drug resistant Pseudomonas aeruginosa.
