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Nabriva Therapeutics to present data at ECCMID supporting ongoing Phase 3 clinical development program for lefamulin

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Nine abstracts support potential for lefamulin as a first-line, empiric treatment for patients with community-acquired bacterial pneumonia

VIENNA, Austria and KING OF PRUSSIA, Pa., April 13, 2017 (GLOBE NEWSWIRE) -- Nabriva Therapeutics AG (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced that it will present data at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) taking place in Vienna, Austria from April 22-25, 2017.

In total, the company will showcase nine abstracts, three of which were selected as oral presentations. These data are part of a growing body of evidence supporting lefamulin’s profile as a potential first-line, empiric treatment for the key pathogens, including multidrug resistant strains, that are known to cause community-acquired bacterial pneumonia (CABP).

“Antibacterial resistance continues to spread, rendering currently available antibiotics less effective. It is critical that new classes of antibiotics continue to be developed to provide physicians treatment options for patients with serious infections,” said Steven P. Gelone, Pharm.D., Chief Development Officer at Nabriva. “With a novel mechanism of action, lefamulin provides a targeted spectrum of activity that covers the most common bacterial causes of CABP, including multidrug resistant strains and atypical pathogens. The data being presented at ECCMID are supportive of our ongoing Phase 3 clinical development program, and we look forward to reporting top-line data from our first pivotal trial, known as LEAP 1, in the third quarter of 2017.”

Highlights of the data to be presented at ECCMID include:

•  Lefamulin demonstrates rapid and extensive penetration of the effect site irrespective of administration route (intravenous or oral). Results are useful in evaluating lefamulin dosing regimens for patients with CABP.

  • Sunday, April 23 at 12:48-12:53 p.m. CEST  
    Oral Presentation #EP0351  
    Presenter: Christopher M. Rubino, Pharm.D.  
    Title: Population Pharmacokinetic (PPK) Analysis for Lefamulin Plasma and Epithelial Lining Fluid (ELF) Exposures using Data from Healthy Subjects   

•  Lefamulin demonstrates specificity for bacterial ribosomes, ruling out any inhibitor effect on the protein synthesis of mammalian cells. Results correlate with findings observed in clinical trials, to date, showing lefamulin is well tolerated.

  • Sunday, April 23, at 2:12-2:17 p.m. CEST
    Oral Presentation #EP0405
    Presenter: Susanne Paukner, Ph.D.
    Title: Lefamulin Selectively Inhibits Bacterial Protein Synthesis    

•  Five abstracts add to a growing compendium of data demonstrating lefamulin’s activity against the key bacteria known to cause CABP, including multidrug resistant strains.

  • Monday, April 24 at 12:30-1:30 p.m. CEST
    Poster #P1331
    Presenter: Susanne Paukner, Ph.D.
    Title: In vitro Activity of Lefamulin against Bacterial Pathogens Commonly Causing Community-Acquired Bacterial Pneumonia (CABP): 2015 SENTRY Data from Europe

    Poster #P1332 
    Presenter: Susanne Paukner, Ph.D.
    Title: In vitro Activity of Lefamulin against Staphylococcus aureus from Hospital-Acquired Pneumonia (HAP) and Community-Acquired Pneumonia (CAP) Patients in Europe  

    Poster #P1333 
    Presenter: Susanne Paukner, Ph.D.  
    Title: In Vitro Activity of Lefamulin against S. aureus Collected from Hospitalized Patients with Bacterial Pneumonia in Europe  

    Poster #P1334  
    Presenter: Susanne Paukner, Ph.D.  
    Title: In Vitro Activity of Lefamulin against Global Collection of Respiratory Pathogens from Paediatric Patients from the 2015 Sentry Program  
    Poster #P1335  
    Presenter: Susanne Paukner, Ph.D.  
    Title: Lefamulin is Highly Active In Vitro Against Multidrug Resistant Mycoplasma genitalium Strains 

•  Two additional posters showcase the pharmacokinetics (PK) and pharmacodynamics (PD) of lefamulin.

  • Monday, April 24 at 12:30-1:30 p.m. CEST  
    Poster #P1336    
    Presenter: Wolfgang W. Wicha, M.S.  
    Title: Pharmacokinetics and Safety of an Oral, Immediate-Release (IR) Tablet Formulation of Lefamulin in Fed and Fasted Healthy Subjects    
      
  • Tuesday, April 25 at 2:30-2:40 p.m. CEST  
    Oral Presentation #OS1021  
    Presenter: Sujata Bhavnani, Pharm.D., M.S.
    Title: Use of Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses to Support the Evaluation of Intravenous and Oral Lefamulin Dosing Regimens for the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP)

About CABP

Based on a 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 estimates that over 5 million adults are treated annually for CABP in the United States.  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.

About LEAP 1 and LEAP 2 Clinical Trial Design

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 U.S. Food and Drug Administration for the development of drugs for CABP and guidance from the European Medicines Agency for the development of antibacterial agents.

About Nabriva Therapeutics AG

Nabriva Therapeutics is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infectives to treat serious bacterial 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. Nabriva Therapeutics’ lead product candidate, 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 Therapeutics 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 United States, Europe and Japan.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva, including but not limited to statements about the development of Nabriva’s product candidates, such as plans for the design, conduct and timelines of Phase 3 clinical trials of lefamulin for CABP, the clinical utility of lefamulin for CABP and Nabriva’s plans for filing of regulatory approvals and efforts to bring lefamulin to market, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption "Risk Factors" in Nabriva’s annual report on Form 10-K filed with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva’s views as of the date of this release. Nabriva anticipates that subsequent events and developments will cause its views to change. However, while Nabriva may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva’s views as of any date subsequent to the date of this release.

CONTACT:

INVESTOR RELATIONS
Will Sargent
Nabriva Therapeutics AG
William.Sargent@nabriva.com
610-813-6406

MEDIA
Katie Engleman
Pure Communications, Inc.
Katie@purecommunicationsinc.com
910-509-3977

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Nabriva Therapeutics US, Inc