Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections,
announced today the results of a pre-clinical study demonstrating
potent anti-inflammatory activity of lefamulin. In a mouse model of
lipopolysaccharide (LPS) induced lung neutrophilia, lefamulin
showed anti-inflammatory properties similar to dexamethasone, a
corticosteroid commonly used for its anti-inflammatory and
immunomodulatory properties. Lefamulin, the company’s novel
pleuromutilin antibiotic, is approved by the U.S. Food and Drug
Administration (FDA) under the brand name XENLETA® for the
treatment of community-acquired bacterial pneumonia (CABP) in
adults. XENLETA is the first IV and oral antibiotic with a novel
mechanism of action approved by the FDA in nearly two decades. The
study was accepted as a pre-print manuscript in bioRxiv.
The research findings reflect the first study investigating the
anti-inflammatory activity of lefamulin. In the mouse model of LPS
induced lung neutrophilia, pretreatment with lefamulin at doses of
35, 70, and 140 mg/kg administered subcutaneously (SC) 30 minutes
before intranasal LPS administration challenge was associated with
almost complete reduction in total cell and neutrophil recruitment
to the lungs at 4 hours post challenge compared with the vehicle
control group (no treatment). Importantly, lefamulin demonstrated
reductions in total cell and neutrophil counts that were similar to
those observed with dexamethasone at all lefamulin doses
tested.
Nabriva has also been awarded grant funding from the Austrian
Research Promotion Agency (FFG) as part of their “Emergency Call
for COVID-19” research. This funding will support additional
in vitro and animal experiments designed to investigate and further
characterize the anti-inflammatory and immunomodulatory properties
of lefamulin, as well as our proprietary library of pleuromutilin
compounds.
“The anti-inflammatory effect lefamulin demonstrated in this
study is very encouraging,” said Jennifer Schranz, MD, Chief
Medical Officer of Nabriva. “Inflammation complicates several
pulmonary diseases including pneumonia and contributes
substantially to morbidity and mortality in patients. We are
excited to partner with the FFG to further investigate the
anti-inflammatory and immunomodulatory properties of lefamulin and
its potential application to inflammatory pulmonary diseases.”
Complete findings of the study titled “Anti-inflammatory
Activity of Lefamulin in a Lipopolysaccharide-Induced Lung
Neutrophilia Model” is available online at:
https://www.biorxiv.org/content/10.1101/2020.06.23.168393v1.full.pdf.
Additional details about the FFG and the emergency call for
COVID-19 research can be found at
https://www.ffg.at/en/news/corona-call.
About XENLETA
XENLETA® (lefamulin) is a first-in-class semi-synthetic
pleuromutilin antibiotic for administration in humans discovered
and developed by the Nabriva Therapeutics team. It is designed to
inhibit the synthesis of bacterial protein, which is required for
bacteria to grow. XENLETA’s binding occurs with high affinity, high
specificity and at molecular sites that are different than other
antibiotic classes. Efficacy of XENLETA was demonstrated in two
multicenter, multinational, double-blind, double-dummy,
non-inferiority trials assessing a total of 1,289 patients with
CABP. In these trials, XENLETA was compared with moxifloxacin and
in one trial, moxifloxacin with and without linezolid. Patients who
received XENLETA had similar rates of efficacy as those taking
moxifloxacin alone or moxifloxacin plus linezolid. The most common
adverse reactions associated with XENLETA include diarrhea, nausea,
reactions at the injection site, elevated liver enzymes, and
vomiting.
About Nabriva Therapeutics
Nabriva Therapeutics is a biopharmaceutical company engaged in
the commercialization and development of innovative anti-infective
agents to treat serious infections. Nabriva Therapeutics received
U.S. Food and Drug Administration approval for XENLETA (lefamulin
injection, lefamulin tablets), the first systemic pleuromutilin
antibiotic for community-acquired bacterial pneumonia (CABP).
XENLETA was discovered in Nabriva Therapeutics laboratories in
Vienna, Austria. For more information, please visit
www.nabriva.com.
About the Austrian Research Promotion Agency
(FFG)
The Austrian Research Promotion Agency (FFG) is the national
funding agency for industrial research and development in Austria.
The purpose of the FFG is to promote research, technology,
development and innovation for the benefit of Austria. All FFG
activities aim to strengthen Austria as a research and innovation
center on the global market and thus help to ensure the long-term
availability of high-quality jobs and maintain the prosperity of
one of the world’s wealthiest countries. For more information,
please visit https://www.ffg.at/en.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
XENLETA is a pleuromutilin antibacterial indicated for the
treatment of adults with community-acquired bacterial pneumonia
(CABP) caused by the following susceptible microorganisms:
Streptococcus pneumoniae, Staphylococcus aureus
(methicillin-susceptible isolates), Haemophilus influenzae,
Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
USAGE
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of XENLETA and other antibacterial
drugs, XENLETA should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
XENLETA is contraindicated in patients with known
hypersensitivity to XENLETA or pleuromutilins.
XENLETA tablets are contraindicated for use with CYP3A4
substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid
XENLETA in patients with known QT prolongation, ventricular
arrhythmias, and patients receiving drugs that may prolong the QT
interval.
Based on animal studies, XENLETA may cause fetal harm. Advise
females of reproductive potential of the potential risk to the
fetus and to use effective contraception.
Clostridium difficile-associated diarrhea (CDAD) has been
reported with nearly all systemic antibacterial agents, including
XENLETA, with severity ranging from mild diarrhea to fatal colitis.
Evaluate if diarrhea occurs.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) for (a) XENLETA
Injection are administration site reactions, hepatic enzyme
elevation, nausea, hypokalemia, insomnia, and headache and (b)
XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme
elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of
XENLETA Injection to 150 mg infused over 60 minutes every 24 hours.
XENLETA Tablets are not recommended in patients with moderate or
severe hepatic impairment due to insufficient information to
provide dosing recommendations.
Avoid XENLETA Injection and Tablets with concomitant strong or
moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of
XENLETA.
Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.
Monitor for adverse reactions of sensitive CYP3A substrates
administered with XENLETA Tablets.
XENLETA has not been studied in pregnant women. Verify pregnancy
status in females prior to initiating XENLETA and advise females to
use contraception during treatment and for 2 days after the final
dose. Lactating women should pump and discard milk for the duration
of treatment with XENLETA and for 2 days after the final dose.
To report SUSPECTED ADVERSE REACTIONS, or administration during
pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA
or the FDA at 1-800-FDA-1088 or
https://www.fda.gov/safety/medwatch.
Please see Full Prescribing Information for
XENLETA.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Nabriva Therapeutics, including but not
limited to statements about its ability to successfully launch and
commercialize XENLETA for the treatment of CABP, including the
availability of and ease of access to XENLETA through major U.S.
specialty distributors, marketing exclusivity and patent protection
for XENLETA, the development of CONTEPO for cUTI, the clinical
utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and
timing of the review of regulatory filings for CONTEPO, efforts to
bring CONTEPO to market, the market opportunity for and the
potential market acceptance of XENLETA for CABP and CONTEPO for
cUTI, the development of XENLETA and CONTEPO for additional
indications, the development of additional formulations of XENLETA
and CONTEPO, plans for making lefamulin available in China, plans
to pursue research and development of other product candidates,
expectations regarding the ability of customers to satisfy demand
for XENLETA with their existing inventory, the sufficiency of
Nabriva Therapeutics’ existing cash resources and its expectations
regarding anticipated revenues from product sales and how far into
the future its existing cash resources will fund its ongoing
operations 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:
Nabriva Therapeutics’ ability to successfully implement its
commercialization plans for XENLETA and whether market demand for
XENLETA is consistent with its expectations, Nabriva Therapeutics’
ability to build and maintain a sales force for XENLETA, the
content and timing of decisions made by the U.S. Food and Drug
Administration and other regulatory authorities, 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 studies 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 CONTEPO for the treatment of cUTI, the
ability to retain and hire key personnel, the availability of
adequate additional financing on acceptable terms or at all and
such other important factors as are set forth in Nabriva
Therapeutics’ annual and quarterly reports and other filings on
file with the U.S. Securities and Exchange Commission. In addition,
the forward-looking statements included in this press release
represent Nabriva Therapeutics’ views as of the date of this press
release. Nabriva Therapeutics anticipates that subsequent events
and developments will cause its views to change. However, while
Nabriva Therapeutics 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 Therapeutics’ views as
of any date subsequent to the date of this press release.
CONTACTS:For InvestorsGary
SenderNabriva Therapeutics plcIR@Nabriva.com
For MediaMike BeyerSam Brown
Inc.mikebeyer@sambrown.com312-961-2502
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