Nabriva Therapeutics AG (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
presentations for lefamulin, the company's advanced clinical-stage
product candidate, at the upcoming IDWeek conference, which will
take place in New Orleans, LA, October 26-30, 2016.
Lefamulin is a novel semi-synthetic antibiotic Nabriva is
developing to be the first pleuromutilin antibiotic available for
systemic administration in humans and is the first new class of
antibiotic to have reached late stage clinical development for
Community Acquired Bacterial Pneumonia (CABP) in over a decade.
Nabriva has initiated two global, registrational Phase 3 clinical
trials investigating lefamulin treatment in patients with
moderate-to-severe CABP.
“Our presentations at IDWeek support the
pharmacokinetic-pharmacodynamic rationale for selection of the IV
and oral dosing in our current Phase 3 program for lefamulin for
the treatment of CABP,” said Steve Gelone, Pharm.D., Chief
Development Officer of Nabriva. “We are looking forward to further
discussions at the conference and continuing to provide data that
differentiates the first systemic pleuromutilin product candidate
for the clinical and research communities.”
The poster presentations are:
Title: Population Pharmacokinetic (PPK)
Analysis for Lefamulin Using Phase 1 Data and Assessment of Optimal
PK Sampling Strategies (OSS) for a Phase 3 Community-Acquired
Bacterial Pneumonia (CABP) Study (Poster No. 1944)Session
Title: Antimicrobial Pharmacokinetics and
PharmacodynamicsSession Timing: Saturday, October
29, 2016Location: New Orleans Ernest N. Morial
Convention Center, Poster HallAuthors: Li Zhang,
M.D., Ph.D.1, Sujata Bhavnani, Pharm.D., M.S.1, Paul G. Ambrose,
Pharm.D., FIDSA1, Wolfgang W. Wicha, M.S.2, Steve Gelone, Pharm.D.3
and Christopher M. Rubino, Pharm.D.1; (1) Institute for Clinical
Pharmacodynamics, Schenectady, NY, (2) Nabriva Therapeutics AG,
Vienna, Austria, (3) Nabriva Therapeutics AG, King of Prussia,
PA
Title: Pharmacokinetic-Pharmacodynamic (PK-PD)
Target Attainment Analyses to Support Oral Lefamulin Dose Selection
in the Treatment of Patients with Community-Acquired Bacterial
Pneumonia (CABP) (Poster No. 1976)Session Title:
Antimicrobial Pharmacokinetics and PharmacodynamicsSession
Timing: Saturday, October 29,
2016Location: New Orleans Ernest N. Morial
Convention Center, Poster HallAuthors: Sujata
Bhavnani, Pharm.D., M.S.1, Li Zhang, M.D., Ph.D.1, Christopher M.
Rubino, Pharm.D.1, Justin C. Bader, Pharm.D., MBA1, Wolfgang W.
Wicha, M.S.2, Steve Gelone, Pharm.D.3 and Paul G. Ambrose,
Pharm.D., FIDSA1; (1) Institute for Clinical Pharmacodynamics,
Schenectady, NY, (2) Nabriva Therapeutics AG, Vienna, Austria, (3)
Nabriva Therapeutics AG, King of Prussia, PA
IDWeek 2016TM is the combined annual meeting of
the Infectious Diseases Society of America (IDSA), the Society for
Healthcare Epidemiology of America (SHEA), the HIV Medicine
Association (HIVMA), and the Pediatric Infectious Diseases Society
(PIDS).
About Nabriva Therapeutics AG
Nabriva Therapeutics is a clinical stage biopharmaceutical
company engaged in the research and development of novel
anti-infective agents to treat serious bacterial infections, with a
focus on the pleuromutilin class of antibiotics. Nabriva's
medicinal chemistry expertise has enabled targeted discovery of
novel pleuromutilins, including both intravenous and oral
formulations of its lead product candidate. Nabriva's lead
pleuromutilin product candidate, lefamulin, is being developed to
be the first systemically available pleuromutilin for human use and
is the first new class of antibiotic to reach late stage clinical
development for community-acquired bacterial pneumonia (CABP) in
over a decade. Nabriva 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 favorable tolerability profile. Nabriva also
intends to further pursue the development of lefamulin for
additional indications, including the treatment of acute bacterial
skin and skin structure infections, and is developing a formulation
of lefamulin appropriate for pediatric use.
Nabriva owns exclusive, worldwide rights to lefamulin, which is
protected by composition of matter patents issued in the
United States, Europe and Japan.
Forward Looking Statements
Any 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 Phase 3
clinical trials 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, 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,
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
report on Form 20-F as filed with the United States 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.
CONTACT:
Will Sargent
Nabriva Therapeutics AG
William.Sargent@nabriva.com
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