Nabriva Therapeutics to Present Data at ECCMID Demonstrating Potential of Lefamulin for Patients with Community-acquired Bacterial Pneumonia

Nabriva Therapeutics to Present Data at ECCMID Demonstrating Potential of Lefamulin for Patients with Community-acquired Bacterial Pneumonia

April 13, 2018 at 7:00 AM EDT
Six abstracts support lefamulin as a potential first-in-class pleuromutilin antibiotic targeting CABP pathogens, including drug resistant phenotypes

DUBLIN, Ireland, April 13, 2018 (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 will present data at the 28thEuropean Congress of Clinical Microbiology and Infectious Diseases (ECCMID) taking place in Madrid, Spain from April 21-24, 2018.

These data are part of a growing body of evidence supporting lefamulin's profile as a promising first-in-class pleuromutilin antibiotic treatment for key pathogens, including multidrug resistant strains, known to cause community-acquired bacterial pneumonia (CABP).

“CABP is associated with a substantial economic and humanistic burden with significant morbidity and mortality for patients. With inappropriate use of currently available treatments, antibacterial resistance continues to rise. It is imperative that new classes of antibiotics continue to be developed to provide physicians treatment options for patients with serious infections,” said Jennifer Schranz, M.D., chief medical officer of Nabriva Therapeutics. “Following the positive results from LEAP 1, lefamulin has shown to provide a complete spectrum of activity that covers the most common bacterial causes of CABP, including multidrug resistant strains and atypical pathogens. We look forward to reporting topline efficacy and safety data from our LEAP 2 oral CABP trial this spring.”

Highlights of the data to be presented at ECCMID include:

Saturday, April 21 at 3:30-4:30 p.m. CEST (9:30 – 10:30 a.m. EDT)

Poster #P0277
Presenter: Steven P. Gelone, Pharm.D.
Session: Clinical trial experience - new antibacterial agents
Title: Lefamulin is Non-inferior to Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia (CABP): The Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

Poster #P0276
Presenter: Steven P. Gelone, Pharm.D.
Session: Clinical trial experience - new antibacterial agents
Title: Lefamulin Demonstrates Favorable Safety and Tolerability in Adults with Community-Acquired Bacterial Pneumonia (CABP) in the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

Poster #P0257
Presenter: Wolfgang W. Wicha, M.Sc.
Session: Pre-clinical PK/PD
Title: Tissue Distribution of [14C]-Lefamulin in the Urogenital Tract in Rats

Poster #P0250
Presenter: Susanne Paukner, Ph.D.
Session: Pre-clinical PK/PD
Title: In Vitro Bactericidal Activity of Lefamulin against Streptococcus pneumoniae Isolates

Poster #P0387
Presenter: Ying Tabak, Ph.D.
Session: Clostridium difficile – clinical news
Title: Correlation of high-risk antibiotic use and hospital-associated C. difficile infections: data from 195 US hospitals

Sunday, April 22 at 12:30-1:30 p.m. CEST (6:30 – 7:30 a.m. EDT)

Poster #P0614
Presenter: Patrick J Scoble, Pharm.D.
Session: Community-acquired respiratory infections
Title: A multicentre evaluation of pathogen distribution in culture positive patients admitted with pneumonia in the US

Poster #P0619
Presenter: Susanne Paukner, Ph.D.
Session: Community-acquired respiratory infections
Title: In Vitro Activity of Lefamulin Against Bacterial Pathogens Collected From Patients with Community- or Hospital- Acquired Respiratory Tract Infections: 2016 SENTRY Data from Europe

Monday, April 23 at 1:30-2:30 p.m. CEST (7:30 – 8:30 a.m. EDT)

Poster #P1823
Presenter: Susanne Paukner, Ph.D.
Session: Resistance in various Gram-positives
Title: In Vitro Activity of Lefamulin against Contemporary Staphylococcus aureus Isolates from Patients in Europe (SENTRY 2016)

The abstracts can be accessed through the ECCMID website. Following the meeting, the posters will be available on the Nabriva website.

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 is evaluating the continued development of lefamulin for additional indications and is developing a formulation of lefamulin appropriate for pediatric use.

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 development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, Nabriva’s plans to enter into arrangements with external collaborators, 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 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.

CONTACTS:

FOR INVESTORS
Dave Garrett
Nabriva Therapeutics plc
david.garrett@nabriva.com
610-816-6657

FOR MEDIA
Benjamin Navon
W2O Group
bnavon@w2ogroup.com
617-337-4166

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Source: Nabriva Therapeutics US, Inc