News | December 4, 2017

Nabriva Therapeutics Announces Completion Of Enrollment In LEAP 2, A Phase 3 Clinical Trial Evaluating Oral Lefamulin For The Treatment Of Community-Acquired Bacterial Pneumonia In Adults

Company remains on track to report topline results in Spring 2018

Dublin, Ireland and King of Prussia, PA (GLOBE NEWSWIRE) - Nabriva Therapeutics plc (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 has completed enrollment in its second lefamulin evaluation against pneumonia (LEAP 2) Phase 3 clinical trial. LEAP 2, which is designed to assess the efficacy and safety of oral lefamulin compared to oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP), completed enrollment of 738 patients. The company anticipates topline clinical results from LEAP 2 to be available in the spring of 2018.

“The lack of truly novel classes of antibiotics in the pipeline is one of the single greatest threats to public health of our lifetime. Our mission is to bring a desperately needed new class of antibiotics to patients and physicians, and today, we are one step closer to achieving this goal,” said Dr. Colin Broom, chief executive officer of Nabriva Therapeutics. “Currently, one in three CABP patients progress to second- or third-line therapy, suggesting available treatment options are not sufficient to combat this infection. Current treatments are associated with limitations due to increasing bacterial resistance and undesirable side effects. Completing enrollment for LEAP 2 represents a significant milestone for what is potentially the first pleuromutilin antibiotic available for IV and oral administration in humans. Based on current projections, we anticipate availability of topline results for LEAP 2 in the spring of 2018.”

In September 2017, Nabriva Therapeutics announced positive topline results from its first Phase 3 clinical trial of lefamulin (LEAP 1), which evaluated the efficacy and safety of intravenous (IV) to oral lefamulin in adult patients with moderate to severe CABP compared to moxifloxacin with or without adjunctive linezolid. In LEAP 1, lefamulin met both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) primary endpoints of non-inferiority compared to moxifloxacin with or without adjunctive linezolid. Lefamulin was shown to be generally well tolerated. LEAP 1 was conducted in patients with more severe infections based on Pneumonia Outcomes Research Team (PORT) classes, whereas LEAP 2 is being tested in moderate disease.

In preclinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that most commonly cause CABP, including multi-drug resistant strains. Due to its unique mechanism of action, cross-resistance between lefamulin and other antibacterial agents commonly used to treat CABP is rare, and lefamulin has shown a low propensity for drug resistance to develop. Furthermore,  the availability of both oral and IV formulations and favorable tolerability profile make it a potential candidate as a first-line empiric monotherapy for In-Hospital, Transition of Care and Community treatment of CABP.

About LEAP 2 Clinical Trial Design
LEAP 2, is a multi-center, randomized, controlled, double-blind, global study comparing oral lefamulin to moxifloxacin, a fluroquinolone antibiotic. LEAP 2 is designed to evaluate the efficacy and safety of oral lefamulin compared to oral moxifloxacin in patients with moderate CABP. All patients enrolled in LEAP 2 have a PORT class severity of 2 to 4 on a scale of 1 to 5, which corresponds to moderate disease.

About CABP
CABP is a leading cause of infectious deaths and hospitalization in the United States. It is a significant driver of hospital readmissions and costs. 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, the company estimates that more than 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 Therapeutics estimates that approximately 3.1 million of these adult CABP patients sought treatment in a hospital 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 Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the research and development of new medicines 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. 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. Nabriva has announced positive topline data for lefamulin from the first of its two global, registrational Phase 3 clinical trials evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (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, with the results of the LEAP 1 trial showing a rate of treatment-emergent adverse events comparable to moxifloxacin with or without linezolid. Nabriva Therapeutics intends to further pursue development of lefamulin for additional indications 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 Nabriva’s ongoing Phase 3 clinical trial 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 market opportunity for and the potential market acceptance of lefamulin for CABP, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, the sufficiency of Nabriva’s existing cash resources 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, whether results of Nabriva’s first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, 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 and quarterly reports on file 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 forwardlooking 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.

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SOURCE: Nabriva Therapeutics US, Inc