Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections, today
announced that in a post-hoc analysis of the Lefamulin Evaluation
Against Pneumonia (LEAP) 1 and LEAP 2 trials by age, XENLETA™
(lefamulin) demonstrated consistently high efficacy and similar
safety and tolerability profiles across all patient groups,
including adults over 65 years of age who are at higher risk of
morbidity and mortality from CABP. CABP is the most common cause of
infectious death in U.S. adults age 65 and older. Results of the
pooled analysis from the pivotal Phase 3 clinical trials of XENLETA
will be presented at the virtual CHEST Annual Meeting, October
18-21, 2020.
“People of advanced age are especially at risk for developing
CABP as a result of a weakened immune system and age-related
comorbidities that increases the chances of hospitalization and
CABP-related complications leading to functional impairment and/or
mortality,” said Jennifer Schranz, MD, Chief Medical Officer of
Nabriva. “Our post-hoc analysis highlights that XENLETA provides a
safe and effective empiric monotherapy alternative to
fluoroquinolones for treatment of CABP in patients with advanced
age and comorbidities.”
In this pooled analysis of 1289 patients from LEAP 1 and LEAP 2
by age group, including adults ages 18-64, 65-74, 75-84, and 85 and
older, 40 percent of the overall pooled patient population was over
65 years of age. Compared to younger patients, patients 65 years of
age and older had higher pneumonia severity scores and were more
likely to have renal impairment, cardiac disease, hypertension,
diabetes or asthma/COPD. The analysis showed that early clinical
response (ECR) and investigator assessment of clinical response
(IACR) at the Test of Cure (TOC) for XENLETA were high
(approximately 90%) and similar to that of moxifloxacin, a current
standard of care fluoroquinolone for CABP, for all age groups. The
adverse event profile and study drug discontinuation rates were
similar across all age groups.
XENLETA is a first-in-class systemic pleuromutilin antibiotic
with a unique mechanism of action that attacks the
difficult-to-treat pathogens in CABP and addresses the challenges
of antibiotic resistance. It is approved by the FDA for the IV and
oral treatment of CABP in adults. Full results of the pooled
analyses presented at the virtual CHEST Annual Meeting can be found
here: https://www.nabriva.com/Portals/0/Nabriva/Posters/CHEST2020/LEF3067_CHEST%202020%20ePoster_LEAP%201%202%20Efficacy%20Safety%20by%20Age.pdf
About CABP
Pneumonia is an infection of the lung that can be serious and
fatal, especially among older adult patients with comorbidities.
There are approximately five million cases of pneumonia in the U.S.
each year, and pneumonia is the fifth leading cause of
hospitalization and one of the leading causes of infection-related
death. Streptococcus pneumoniae is the most common cause of
bacterial pneumonia in the U.S. According to recent data from the
SENTRY Antimicrobial Surveillance Program, in the U.S.,
approximately 30 to 60 percent of S. pneumoniae, depending on
region, are macrolide resistant. In addition to macrolides,
fluoroquinolones are another common treatment option for CABP. This
broad-spectrum class is an effective option; however,
fluoroquinolones carry boxed warnings for several significant
safety concerns.
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. For more information, please visit www.xenleta.com.
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 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. Nabriva entered into an exclusive
agreement with subsidiaries of Merck & Co.
Inc., Kenilworth, N.J., USA to market, sell and distribute
SIVEXTRO® (tedizolid phosphate) in the United
States and certain of its territories. For more
information, please visit https://www.nabriva.com.
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 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 Investors
Gary SenderNabriva Therapeutics plcIR@Nabriva.com
For Media
Mike BeyerSam Brown Inc.mikebeyer@sambrown.com312-961-2502
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