Nabriva Therapeutics Announces Enrollment Completion for Phase 3 Clinical Trial

Nabriva Therapeutics AG recently announced it has completed enrollment in its first lefamulin evaluation against pneumonia (LEAP 1) Phase 3 clinical trial. LEAP 1, which is designed to assess the efficacy and safety of lefamulin (IV/oral) compared to moxifloxacin (IV/oral) in patients with moderate-to-severe community-acquired bacterial pneumonia (CABP), met its enrollment target of 550 patients. The company anticipates availability of top-line clinical data from LEAP 1 in the third quarter of 2017.

“This is a potentially transformational year for Nabriva with the completion of enrollment for LEAP 1 and top-line clinical data anticipated in the third quarter,” said Dr. Colin Broom, Chief Executive Officer of Nabriva. “We will continue to enroll our second pivotal Phase 3 clinical trial, LEAP 2, which is evaluating efficacy and safety of oral lefamulin for the treatment of patients with moderate CABP. Based on current projections, we expect to complete patient enrollment for LEAP 2 in the fourth quarter of 2017 and anticipate availability of top-line data for LEAP 2 in the first quarter of 2018.”

“Bacterial resistance to commonly prescribed antibiotics for the treatment of CABP continues to rise globally, rendering those antibiotics less effective and increasing the need for new classes of therapies,” said Elyse Seltzer, MD, Chief Medical Officer of Nabriva Therapeutics. “As the potential first-in-class pleuromutilin available for systemic administration in humans, lefamulin could provide a monotherapy for patients with moderate-to-severe CABP, with targeted activity against the most common pathogens, including multidrug resistant strains. Additionally, we believe that it is critically important to develop antibiotics that align with the principles of antibiotic stewardship and offer a new, targeted option for the empiric treatment of these patients. We look forward to sharing the results from this trial with the scientific and medical communities.”

Based on a combined analysis of the US 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 estimates that over 5 million adults are treated annually for CABP in the US. Additionally, based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva estimates that approximately 3 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.

Nabriva’s first pivotal Phase 3 clinical trial, LEAP 1, is a multi-center, randomized, controlled, double-blind, international study comparing lefamulin to moxifloxacin, a fluoroquinolone antibiotic. LEAP 1 is designed to evaluate the efficacy and safety of lefamulin (IV/oral) compared to moxifloxacin (IV/oral), with or without linezolid, in 550 patients with moderate to severe CABP. Linezolid (or matching placebo for the lefamulin arm) can be added to treatment if an investigator suspects that a patient is infected with methicillin-resistant S. aureus (MRSA) prior to randomization, as moxifloxacin is not approved to treat MRSA. All patients enrolled in this trial have a Pneumonia Outcomes Research Team (PORT) severity of at least 3 on a scale of 1 to 5, which corresponds to moderate-to-severe clinical disease. Nabriva’s second pivotal Phase 3 clinical trial, LEAP 2, is a multi-center, randomized, controlled, double-blind, international study comparing oral lefamulin to moxifloxacin. LEAP 2 is designed to evaluate the efficacy and safety of oral lefamulin compared to oral moxifloxacin in subjects with moderate CABP. All patients enrolled in this trial have a PORT severity of 2 to 4 on a scale of 1 to 5, which corresponds to moderate disease. Nabriva is targeting the enrollment of approximately 738 patients in LEAP 2. Both Phase 3 clinical trials of lefamulin were designed to follow draft guidance published by the US FDA for the development of drugs for CABP and guidance from the European Medicines Agency for the development of antibacterial agents.

Nabriva Therapeutics is a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infectives to treat serious infections, with a focus on the pleuromutilin class of antibiotics. Nabriva Therapeutics’ medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate, lefamulin. Lefamulin is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Lefamulin is currently being evaluated in two global, registrational Phase 3 clinical trials in patients with moderate-to- severe CABP. Nabriva believes lefamulin is well-positioned for use as a first-line empiric monotherapy for the treatment of moderate-to-severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral, and IV formulations and a favorable tolerability profile. Nabriva Therapeutics intends to further pursue development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections (ABSSSI), and is developing a formulation of lefamulin appropriate for pediatric use.

Nabriva Therapeutics owns exclusive, worldwide rights to lefamulin, which is protected by composition of matter patents issued in the US, Europe, and Japan.