Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical
company engaged in the commercialization and development of
innovative anti-infective agents to treat serious infections,
announced positive topline results from their Phase 1 clinical
trial that assessed the safety and pharmacokinetics (PK) of oral
and intravenous (IV) XENLETA® (lefamulin) in adult patients with
cystic fibrosis (CF).
“We are excited to share positive topline results from this
important study of XENLETA in patients with CF,” said Christine
Guico-Pabia, M.D., MBA, MPH, Nabriva’s Chief Medical Officer. “The
data indicate that the PK of XENLETA in CF patients is consistent
with that observed in previous single-dose healthy volunteer
studies evaluating the approved oral and IV dosing for adults with
community-acquired bacterial pneumonia (CABP). In addition, XENLETA
was well-tolerated and the adverse event profile in CF patients was
consistent with that described across our clinical program.
Dr. Guico-Pabia added, “XENLETA has been demonstrated to be a
potent anti-staphylococcal antibiotic in in vitro and clinical
studies, including against methicillin-resistant S. aureus (MRSA).
There are limited treatment options for the management of bacterial
exacerbations in CF patients caused by S. aureus and the results of
this study support the potential utility of XENLETA in this
difficult to treat patient population. We would like to thank the
study participants, investigators, and the Cystic Fibrosis
Foundation for their support of this important study and look
forward to sharing the complete results with the medical community
in the first half of 2023.”
About the Trial
The Phase 1 trial is an open-label, randomized,
single-dose, crossover study to assess the safety and
pharmacokinetics of oral (600 mg) and IV (150 mg) XENLETA in adult
patients with cystic fibrosis. The dosing utilized in this study is
consistent with the FDA approved dosage for the treatment of adults
with CABP.
More information can be found at
ClinicalTrials.gov -NCT05225805.
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 injection, lefamulin tablets),
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. 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.
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 included diarrhea, nausea, reactions at the injection site,
elevated liver enzymes, and vomiting. For more information, please
visit www.XENLETA.com.
Indication and Important Safety Information
IndicationXENLETA 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.
UsageTo 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
CONTRAINDICATIONSXENLETA 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 PRECAUTIONSXENLETA 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.
Clostridioides 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 REACTIONSThe 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 POPULATIONSIn 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 at
www.XENLETA.com.
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 the potential of XENLETA to be a
treatment option for CF patients with bacterial infections, the
timing of dosing, completion and availability of data from the
Phase 1 clinical trial of XENLETA, the clinical utility of XENLETA
for CABP, SIVEXTRO for ABSSSI and of CONTEPO for cUTI, the impact
of macro events on sales of SIVEXTRO and XENLETA, plans for and
timing of the review of regulatory filings for XENLETA and CONTEPO,
efforts to bring CONTEPO to market, the market opportunity for and
the potential market acceptance of XENLETA for CABP, SIVEXTRO for
ABSSSI and CONTEPO for cUTI, the development of XENLETA and CONTEPO
for additional indications, plans to pursue research and
development of other product candidates, expectations regarding the
impact of the interruptions resulting from COVID-19 on its
business, 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: 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 extent of business interruptions
resulting from the infection causing the COVID-19 outbreak or
similar public health crises, 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.
References
- Cystic Fibrosis Foundation Patient Registry – Annual Data
Report 2020
- Cystic Fibrosis Foundation Patient Registry – Annual Data
Report 2018
- Dasenbrook EC, et al. JAMA 2010;303(23):2386-2392
CONTACTS:
For InvestorsKim AndersonNabriva Therapeutics
plcir@nabriva.com
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