News & Publications Careers Contact Us ABOUT NABRIVA PIPELINE & RESEARCH FOR INVESTORS PIPELINE & RESEARCH Home / Pipeline & Research Our Goal is to Develop Novel Antibiotics In recent years, the effectiveness of many antibiotics has declined due to growing antibiotic resistance and cross-resistance (when bacterial strains become resistant to multiple classes of antibiotics). As a result, healthcare providers have fewer options when treating serious infections, and they may be forced to use antibiotics that may be more toxic to patients and frequently more expensive and less effective. In 2010, the World Health Organization (WHO) stated that antibiotic resistance is one of the three greatest threats to human health. At Nabriva, our team is committed to addressing this urgent need. CURRENT PIPELINE LEFAMULIN CONTEPO BC-7013 GRANTS Our Current Pipeline The following table summarizes the indications for which we are developing product candidates and the status of development. About Our Investigational Therapies Lefamulin This semi-synthetic compound inhibits the synthesis of bacterial protein, which is required for bacteria to grow. It acts by binding to the peptidyl transferase center, or PTC, on the bacterial ribosome in such a way that it interferes with the interaction of protein production at two key sites known as the “A” site and the “P” site, resulting in the inhibition of bacterial proteins and the cessation of bacterial growth. Its binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. We have completed two pivotal Phase 3 trials evaluating the safety and efficacy of lefamulin in for the treatment of adults with community-acquired bacterial pneumonia (CABP). In our first clinical trial in patients with CABP (LEAP-1), seven-days of intravenous (IV) to oral lefamulin in adults with moderate to severe CABP was compared to moxifloxacin (IV/oral), with or without linezolid. In the LEAP 2 trial, five-days of oral lefamulin was compared to seven-days of oral moxifloxacin in adults with moderate CABP. Both trials were multi-center, randomized, controlled, double-blind and enrolled patients globally. Lefamulin met all U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) primary endpoints in both LEAP 1 and LEAP 2 and was shown to be generally well tolerated. As a result of the favorable safety and tolerability profile we have observed in our clinical trials to date, we believe Lefamulin will present fewer potential complications as than current therapies. In December 2018, we completed the submission of two New Drug Applications (NDAs) to the FDA for the oral and IV formulations of lefamulin for the treatment of CABP. In February 2019, these applications were accepted by the FDA, granted priority review and given a PDUFA date of August 19, 2019. Both formulations of lefamulin were granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA. On August 19, 2019, the FDA Approved Xenleta™(lefamulin) for both Oral And IV use. Nabriva intends to work with a commercial partner to make lefamulin available to patients in the European Union. In July 2020, the European Commission issued a legally binding decision for approval of the marketing authorization application for XENLETA™ (lefamulin) for the treatment of community-acquired pneumonia in adults following a review by the European Medicines Agency. In July 2020, our partner, Sunovion Pharmaceuticals Canada Inc., received approval for Xenleta®(lefamulin) from Health Canada for the treatment of community-acquired pneumonia (CAP) in adults. Based on our research, we also believe that the availability of both IV and oral formulations of lefamulin, and an option to switch to oral treatment, could reduce the length of a patient’s hospital stay and the overall cost of care. Based on a combined analysis of the U.S. Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that more than 5 million adults visit a site of care for CABP treatment in the United States each year. Based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that approximately 3 million of these adult CABP patients are diagnosed in a hospital setting, where most are then treated as in-patients with IV and oral antibiotics or as Transition of Care out-patients with oral antibiotics following hospital discharge or release. To learn more about CABP and why new treatments are needed, click here. Nabriva owns exclusive, worldwide rights to lefamulin. We intend to further pursue the development of this antibiotic and are developing a formulation that is also appropriate for pediatric use. We believe that lefamulin's product profile also provides the opportunity to expand to additional indications beyond pneumonia, such as the treatment of acute bacterial skin and skin structure infections (ABSSSI), sexually transmitted infections (STIs), ventilator-associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP), osteomyelitis, and prosthetic joint infections. Attributes that make lefamulin well suited for use as a first-line empiric monotherapy for the treatment of CABP include: Novel class and new mechanism of action Excellent PK-PD profile Flexible IV & oral formulations and short course of monotherapy Complete spectrum of coverage of main CABP pathogens, including multi-drug resistant pathogens Demonstrated efficacy and favorable safety and tolerability profile CONTEPO CONTEPO™ (previously referred to as ZTI-01) is an investigational, first-in-class intravenous (IV) epoxide antibiotic with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR strains that threaten hospitalized patients. 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, 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 NDA to the 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. In December 2019, Nabriva resubmitted its New Drug Application (NDA) to the FDA for CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva anticipates a six-month review period by the FDA. In June 2020, Nabriva received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) resubmission seeking marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. Although Nabriva’s European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at the manufacturing partners that could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions. In general, previously identified product quality and facility inspection related observations at our contract manufacturing partners are required to be satisfactorily resolved before the NDA may be approved. The FDA did not request any new clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO in the CRL. The FDA has granted CONTEPO™ 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) CONTEPO’s inhibition of cell wall formation occurs at an early stage in cell wall synthesis, differentiating its mechanism of action from all other injectable antibiotics. These designations make CONTEPO™ eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act. CONTEPO™ is an investigational medication that has not been found by the U.S. FDA to be safe or effective for any indication. BC-7013 BC-7013 is a semi-synthetic compound derived from pleuromutilin with the potential to be developed for the topical treatment of Gram-positive infections, including uncomplicated skin and skin structure infections (uSSIs). We have completed a Phase 1 clinical trial for BC-7013. Nabriva Grants Programs As part of our commitment to improving patient care and to advancing medical and scientific knowledge about our products, Nabriva is pleased to offer funding for two important grant programs — one that supports independent Medical Education programs for healthcare professionals and one that supports Investigator-Initiated Research studies. Click below to learn more. Educational Grants Investigator-Initiated Research Grants Review Our Data See a complete list of poster presentations and published research to date. View News & Publications Learn More About Our Pleuomutilin Antibiotic Research Nabriva is also pursuing innovative solutions for other infectious indications. Explore Pleuromutilins Research Learn More About Our Fosfomycin Antibiotic Research Nabriva is also pursuing innovative solutions for other infectious indications. Explore Fosfomycin Research Nabriva Response to COVID-19 Thank you to all the healthcare professionals for your tireless service on the frontlines of this pandemic. Due to COVID-19, the FDA has reported shortages of key drugs, including select antibiotics. Xenleta® (lefamulin) may be an alternative regimen for patients in need. Nabriva wants to reassure you that we have sufficient inventory of XENLETA IV and Oral tablets, available through designated specialty pharmacies or specialty distributors. Learn more at www.XENLETA.com. Again, to all the medical professionals, please be safe, take care of yourself and stay well. Best, Ted Schroeder CEO, Nabriva Therapeutics Continue to site Privacy Notice Patents Imprint Disclaimer Contact Us Careers Sitemap © Nabriva Therapeutics plc, Ireland Registration No. 599588, 25-28 North Wall Quay, Dublin 1, Ireland