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 that it will present data on the pooled results
from completed Phase 3 trials of XENLETA™ (lefamulin) at the CHEST
Annual Meeting 2019, to be held October 19-23 in New Orleans.
XENLETA is a first-in-class pleuromutilin antibiotic for the
intravenous (IV) and oral treatment of community-acquired bacterial
pneumonia (CABP) in adults and is now commercially available in the
United States.
“The clinical community desperately needs new classes of
antibiotics with different mechanisms of action that have targeted,
potent antimicrobial activity and improved safety and tolerability
over existing therapies,” said Jennifer Schranz, M.D., Chief
Medical Officer of Nabriva Therapeutics. “With the arrival of the
flu season and the increased risk of respiratory infections during
the winter months, XENLETA’s availability is more important than
ever. We look forward to informing the CHEST professional community
about the benefits and safety profile of this new antibiotic as a
short-course, empiric monotherapeutic treatment option for adults
with CABP.”
Results from the pivotal Lefamulin Evaluation Against Pneumonia
(LEAP) 1 and LEAP 2 Phase 3 clinical trials will be featured in
three e-poster presentations during a moderated grand-rounds
session at the CHEST meeting. These studies demonstrated that
XENLETA is a well-tolerated, new IV and/or oral antimicrobial
monotherapy for the empiric treatment of adults with CABP and a
clinical alternative to moxifloxacin, a current standard of care
fluoroquinolone. The data also showed that early clinical response
rates of XENLETA, as well as health-related quality of life
improvements, were high and similar to that of moxifloxacin in
at-risk groups, including patients age 65 years or greater, who are
at the highest risk of morbidity and mortality.
Details for the upcoming presentations are as follows:
Title: Efficacy of Lefamulin Versus
Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia:
Results of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 And
LEAP 2 Double-Blind Noninferiority Phase 3 Clinical
TrialsPresenter: Christian E. Sandrock,
M.D.Date and Time: Monday, October 21, 2:30 p.m.
– 3:15 p.m. CT Poster #: E1006
This pooled efficacy assessment of the LEAP 1 and 2 studies
reported the early clinical response (ECR) at 96 ± 24 hours after
first dose of study drug among 1289 randomized patients, and the
investigator assessment of clinical response (IACR) at test-of-cure
(TOC): five to 10 days after last dose of study drug in the
modified intent-to-treat population – those receiving ≥1 dose of
study drug and in the clinically evaluable populations. In addition
to efficacy overall, analyses stratified by Pneumonia Outcomes
Research Team (PORT) Risk Class, from both pooled and individual
trials, were presented. CABP patients treated with lefamulin
demonstrated high response rates for ECR and IACR and was
noninferior to moxifloxacin. Response rates with lefamulin IV
and/or oral therapy remained high across the indices of
severity.
Title: Safety and Tolerability of Lefamulin
Versus Moxifloxacin in Adults with Community-Acquired Bacterial
Pneumonia: Results of the Lefamulin Evaluation Against Pneumonia
(LEAP) 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical
TrialsPresenter: Christian E. Sandrock,
M.D.Date and Time: Tuesday, October 22, 1:00 p.m.
– 2:00 p.m. CTPoster #: E1053
The objective of this pooled safety assessment of the LEAP 1 and
2 studies was to identify treatment-emergent adverse events among
patient groups treated with lefamulin versus moxifloxacin. Pooled
data from the LEAP 1 and LEAP showed similar safety and
tolerability profiles for lefamulin and moxifloxacin.
Title: Efficacy and Safety of Lefamulin Versus
Moxifloxacin for Atypical Respiratory Pathogens in Adults with
Community-Acquired Bacterial Pneumonia: Pooled Results from the
Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Double
Blind Noninferiority Phase 3 Clinical
TrialsPresenter: David MarianoDate and
Time: Tuesday, October 22, 1:00 p.m. – 2:00 p.m.
CTPoster #: E1142
This analysis was to determine the safety and efficacy of
lefamulin versus moxifloxacin in patients with atypical respiratory
pathogens including Mycoplasma pneumoniae, Legionella pneumophila,
and Chlamydophila pneumoniae. In the pooled patient population,
short-course therapy (five to seven days) with lefamulin for
atypical pathogens resulted in high ECR responder and IACR success
rates and was generally well tolerated in comparison to
moxifloxacin.
About CABP
Community-acquired bacterial pneumonia (CABP) is a lung
infection and the most common type of pneumonia. In CABP, infection
occurs outside of hospitals or other health care facilities. The
most common cause of CABP in the United States is Streptococcus
pneumoniae. This type of pneumonia can occur on its own following
the flu and can cause shortness of breath, fever and cough. It is
estimated that there are between five to six million cases of CABP
in the U.S. annually.
About Nabriva Therapeutics plc
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), the first systemic pleuromutilin antibiotic for
community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics
is also developing CONTEPO™ (fosfomycin) for injection, a potential
first-in-class epoxide antibiotic for complicated urinary tract
infections (cUTI), including acute pyelonephritis. For more
information, please visit www.nabriva.com.
About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic
pleuromutilin antibiotic for systemic 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.
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 FDA at 1-800-FDA-1088 or www.fda.gov/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 launch and commercialization of XENLETA
for the treatment of CABP, 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 XENLETA and 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 to pursue research and
development of other product candidates, the sufficiency of Nabriva
Therapeutics’ 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: 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 and prepare for commercial launch of XENLETA on the
timeline expected, or at all, 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 or of XENLETA for the treatment of CABP, the
ability to retain and hire key personnel, the sufficiency of cash
resources and need for additional financing 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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