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Nabriva Presents Data on Lefamulin at the American Society of Microbiology (ASM) Microbe 2016 Conference

Excellent In Vitro Activity Demonstrated Against Mycoplasma pneumoniae, Including Macrolide-Resistant Strains

Top-Line Data from Phase 3 Community Acquired Bacterial Pneumonia Studies of Lefamulin Expected 2H 2017

VIENNA, Austria, and KING OF PRUSSIA, Pa., June 20, 2016 (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, announced today research findings for lefamulin, the Company’s lead product candidate.

Lefamulin is a novel semi-synthetic antibiotic Nabriva is developing to be the first pleuromutilin antibiotic available for systemic administration in humans and is the first new class of antibiotic to have reached late stage clinical development for Community Acquired Bacterial Pneumonia (CABP) in over a decade. Nabriva has initiated two global, registrational Phase 3 clinical trials investigating lefamulin treatment in patients with moderate-to-severe CABP. As reported at the ASM Microbe 2016 Conference on Sunday, lefamulin demonstrated excellent in vitro activity against all tested isolates of Mycoplasma pneumoniae, a common cause of CABP associated with significant morbidity and mortality. Importantly, lefamulin’s in vitro activity against M. pneumoniae was unaffected by resistance to macrolides, which have been widely used against M. pneumoniae.

In Vitro Activity of Lefamulin Against Macrolide-Susceptible (MSMP) and Macrolide-Resistant Mycoplasma pneumoniae (MRMP) from the United States, Europe, and China (Abstract 3972)

Key Findings:
Lefamulin and four comparator antibiotics were tested against 50 unique isolates of M. pneumoniae, including 36 macrolide-resistant isolates obtained between 2009 and 2013 from the US and China. Lefamulin demonstrated potent in vitro activity against M. pneumoniae, regardless of resistance phenotype, inhibiting all 50 strains at concentrations < 0.004 µg/mL. Importantly, lefamulin was shown to have the lowest MIC90 value against all 36 strains of Macrolide-resistant M. pneumoniae (MRMP) compared with azithromycin, erythromycin, moxifloxacin and tetracycline.

Lefamulin’s bactericidal (bacterial killing) effect against eight isolates, including six MRMP isolates was also evaluated. The minimum bactericidal concentration (MBC) measured were as follows:

Strain Susceptibility MIC [µg/mL] MBC [µg/mL]
1Macrolide-susceptible0.00050.002
2Macrolide-susceptible0.0010.002
3Macrolide-resistant0.0010.004
4Macrolide-resistant0.0020.008
5Macrolide-resistant0.0020.008
6Macrolide-resistant0.0010.004
7Macrolide-resistant0.0020.004
8Macrolide-resistant0.0020.008

Mycoplasma pneumonia is a major cause of CABP, estimated to be responsible for up to 50% of cases in children. Clinicians are concerned with the increasing prevalence of clinically significant resistance to macrolides in M. pneumoniae, spreading from Asia and Europe to the United States,” commented Ken B. Waites, M.D, F(AAM), Professor of Pathology and Director, Diagnostic Mycoplasma Laboratory at the University of Alabama at Birmingham. “These data demonstrate potent in vitro activity of lefamulin against all strains of M. pneumoniae tested regardless of resistance phenotype. Further assessment of lefamulin for the treatment of respiratory infections caused by M. pneumoniae is warranted.”

“Lefamulin has consistently demonstrated potent in vitro activity against the most common gram-positive, gram-negative, and atypical bacterial causes of CABP, including multi-drug resistant strains. The data reported at ASM add to the robust in vitro evidence supporting the potential of this promising agent in the treatment of CABP,” Steve Gelone, Pharm.D., Chief Development Officer of Nabriva. “We continue to enroll patients in our Phase 3 development program with moderate-to-severe CABP, and based on our progress, we remain on track to report top-line data in the second half of 2017.”

About Nabriva Therapeutics AG

Nabriva Therapeutics is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva's medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations of its lead product candidate. Nabriva's lead pleuromutilin product candidate, lefamulin, is being developed to be the first systemically available pleuromutilin for human use and is the first new class of antibiotic to reach late stage clinical development for CABP in over a decade. 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 favorable tolerability profile. Nabriva also intends to further pursue the development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections, and is developing a formulation of lefamulin appropriate for pediatric use.

Nabriva 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 in vitro studies, 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 20-F as filed with the United States 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: Will Sargent Nabriva Therapeutics AG William.Sargent@nabriva.com

Source:Nabriva Therapeutics US, Inc