Nabriva Therapeutics announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for Contepo (fosfomycin for injection) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.
Contepo, an investigational epoxide intravenous (IV) antibiotic, has broad spectrum activity against Gram-negative and Gram-positive pathogens, including multi-drug resistant strains such as ESBL-producing Enterobacteriaceae. Compared with other injectable antibiotics, Contepo works by inhibiting cell wall formation at an early stage in cell wall synthesis. According to the Company, “Contepo utilizes a new dosing approach to optimize the compound’s pharmacokinetics and pharmacodynamics.”
The NDA includes data from the Phase 2/3 multicenter, randomized, double-blind ZEUS trial (N=465), which demonstrated statistical non-inferiority of Contepo to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis (64.7% vs 54.5% success rate, respectively). Separately, non-clinical data have also demonstrated that Contepo acts synergistically with some other antibiotics to improve bacterial killing and restore susceptibility to agents that may otherwise be resistant.
Contepo has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of cUTI, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia/ ventilator-associated bacterial pneumonia, and acute bacterial skin and skin structure infections.
“We look forward to working with the FDA during the review process with the goal of bringing Contepo, a potentially first-in-class intravenous antibiotic, to clinicians and patients,” said Dr Jennifer Schranz, chief medical officer of Nabriva Therapeutics.
For more information visit Nabriva.com.