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 28th European 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 #P0277Presenter: Steven P. Gelone, Pharm.D. Session:
Clinical trial experience - new antibacterial agentsTitle:
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 #P0276Presenter: Steven P. Gelone, Pharm.D.Session:
Clinical trial experience - new antibacterial agentsTitle:
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 #P0257Presenter: Wolfgang W. Wicha, M.Sc.Session:
Pre-clinical PK/PDTitle: Tissue Distribution of [14C]-Lefamulin in
the Urogenital Tract in Rats
Poster #P0250Presenter: Susanne Paukner, Ph.D.Session:
Pre-clinical PK/PDTitle: In Vitro Bactericidal Activity of
Lefamulin against Streptococcus pneumoniae Isolates
Poster #P0387Presenter: Ying Tabak, Ph.D.Session: Clostridium
difficile – clinical newsTitle: 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 #P0614Presenter: Patrick J Scoble, Pharm.D.Session:
Community-acquired respiratory infectionsTitle: A multicentre
evaluation of pathogen distribution in culture positive patients
admitted with pneumonia in the US
Poster #P0619Presenter: Susanne Paukner, Ph.D.Session:
Community-acquired respiratory infectionsTitle: 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 #P1823Presenter: Susanne Paukner, Ph.D.Session:
Resistance in various Gram-positivesTitle: 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 plcNabriva
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 StatementsAny 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 INVESTORSDave GarrettNabriva Therapeutics
plcdavid.garrett@nabriva.com 610-816-6657
FOR MEDIABenjamin NavonW2O
Groupbnavon@w2ogroup.com 617-337-4166
Nabriva Therapeutics (NASDAQ:NBRV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Nabriva Therapeutics (NASDAQ:NBRV)
Historical Stock Chart
From Apr 2023 to Apr 2024