Our Research Program
Fosfomycin IV has an extensive history from markets outside the U.S., where it has been utilized for over 45 years in nine indications. CONTEPO utilizes a new dosing approach, developed by Zavante, to optimize the compound’s pharmacokinetics and pharmacodynamics.
The company believes that these attributes, along with the positive clinical experience worldwide, support CONTEPO as a first-line treatment for complicated urinary tract infections (cUTI) suspected to be caused by MDR pathogens. Approximately 25% of cUTIs are caused by MDR bacteria and limited treatment options are available. In addition, non-clinical data have shown that CONTEPO acts synergistically with certain other antibiotics to improve bacterial killing and restore susceptibility to agents otherwise demonstrating resistance.
The CONTEPO development program is initially focused on obtaining regulatory approval for the treatment of cUTI, including acute pyelonephritis, with the pivotal ZEUS™ study (ZTI-01 Efficacy and Safety study). In the ZEUS study, CONTEPO met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in this patient population. In October 2018, Nabriva Therapeutics submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to seek marketing approval for CONTEPO™ to treat cUTIs, including acute pyelonephritis. On April 30, 2019, we received a Complete Response Letter (CRL) from the FDA for the NDA. The CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA. Nabriva plans to request a “Type A” meeting to discuss the FDA’s findings. The FDA did not request any new clinical data and did not raise any concerns with regard to the safety of CONTEPO.
The FDA has granted CONTEPO Qualified Infectious Disease Product (QIDP) and Fast Track designations for:
- Complicated urinary tract infections (cUTI)
- Complicated intra-abdominal infections (cIAI)
- Hospital-acquired bacterial pneumonia (HABP) / Ventilator-associated bacterial pneumonia (VABP)
- Acute bacterial skin and skin structure infections (ABSSSI)