Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the Company’s marketing authorization application (MAA) for both the intravenous (IV) and oral formulations of lefamulin, a potentially first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired pneumonia (CAP) in adults 18 years of age and older, has been submitted to the European Medicines Agency (EMA). If approved, Nabriva intends to work with a commercial partner to make lefamulin available to patients in the EU.
The MAA filing is supported by two pivotal, Phase 3 clinical trials (known as LEAP 1 and LEAP 2) that evaluated the safety and efficacy of IV and oral lefamulin compared to moxifloxacin in the treatment of adults with CAP. LEAP 1 was designed with the option to switch from IV to oral administration, while LEAP 2 was designed as a short course, 5-day, oral only treatment with lefamulin. In both LEAP 1 and LEAP 2, lefamulin was demonstrated to be non-inferior to moxifloxacin, and met both the EMA and U.S. Food and Drug Administration (FDA) primary and secondary efficacy endpoints for the treatment of CAP. Lefamulin was also shown to be generally well-tolerated when administered either orally or intravenously.
“The MAA filing for lefamulin represents another major milestone for Nabriva as we continue to make significant progress toward our commitment of addressing the urgent and unmet medical need for novel anti-infective agents for patients with serious infections,” said Dr. Jennifer Schranz, chief medical officer of Nabriva Therapeutics. “The spread of bacterial resistance and the growing recognition of certain adverse effects associated with guideline concordant treatment options has significantly complicated selection of empiric antibiotic therapy for patients with CAP. Effective alternative monotherapy options with a novel mechanism of action are urgently needed to address this growing unmet medical need.”
Based on Nabriva Therapeutics’ combined analysis of the U.S. Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that more than five million adults are treated annually for community-acquired bacterial pneumonia (CABP) in the United States. Additionally, based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that approximately three million of these adult CABP patients are diagnosed in an in-patient hospital and/or emergency department setting, where most are then treated with in-patient IV and oral antibiotics or out-patient oral antibiotics prescribed for use following hospital discharge or release.
Lefamulin is a semi-synthetic pleuromutilin antibiotic with potential to be first-in-class for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. Lefamulin’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Based on results from its two global, Phase 3 clinical trials, Nabriva Therapeutics believes lefamulin is well-positioned for use as a first-line monotherapy for the treatment of CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, availability of oral and IV formulations and a generally well-tolerated safety profile. Nabriva Therapeutics believes lefamulin represents a potentially important new treatment option for the approximately five to six million adults in the United States diagnosed with CABP each year.
This article was republished using materials from Nabriva’s press release.