Nabriva Therapeutics to Present Data at ASM Microbe Demonstrating Potential of Lefamulin for Patients with Community-acquired...
June 21 2019 - 7:00AM
Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage
biopharmaceutical company engaged in the development of innovative
anti-infective agents to treat serious infections, today announced
that it will present data at ASM Microbe 2019 to be held June
20 - 24 in San Francisco, CA.
“At Nabriva, we are committed to the fight
against the growing threat of antimicrobial resistance in CABP and
cUTIs and bringing novel anti-infective agents to patients in need.
The ASM delegation is an important partner in this struggle,” said
Jennifer Schranz, M.D., Chief Medical Officer of Nabriva
Therapeutics. “At ASM Microbe, we will present additional
data from our phase 3 lefamulin and CONTEPO clinical studies that
further support efficacy by pathogen for CABP and cUTI,
respectively.”
Highlights of the data to be presented at ASM Microbe 2019
include:
Friday June 21st
Session: P404 – CIV01 – Clinical Studies of Adult
Infectious Diseases: Urinary Tract Infections
Time: 11:00 a.m. – 12:00 p.m. & 4:00 p.m. – 5:00
p.m.
CIV-148 – Fosfomycin for Injection (FOS) Versus (vs)
Piperacillin-Tazobactam (PIP-TAZ) for Treating Complicated Urinary
Tract Infections (cUTI) and Acute Pyelonephritis (AP): Further
Analyses of the ZEUS Study
Saturday June 22nd
Session: P508 – AAR02 – Antimicrobial Agents: Mechanisms
of Resistance in Gram-Negative Bacteria Time:
11:00 a.m. – 12:00 p.m. & 4:00 p.m. – 5:00 p.m.
AAR-666 – In Vitro and In Vivo Effects of Fosfomycin Resistant
Mutants on Bacterial Growth and Efficacy in the Murine UTI
Model
Session: P515 – AAR09 – Pharmacological Studies of Novel
Investigational Agents (Phase 2/3) Time: 11:00
a.m. – 12:00 p.m. & 4:00 p.m. – 5:00 p.m. AAR-786 –
Lefamulin Activity against Respiratory Tract Pathogens Collected in
the 2017 Global SENTRY Surveillance Program
AAR-785 – Lefamulin Activity against Bacterial Pathogens
Commonly Associated with Acute Bacterial Skin and Skin Structure
Infections (ABSSSI) Collected in the 2017 Global SENTRY
Surveillance Program
Sunday June 23rd
Session: P553 – CIV01 – Clinical Studies of Adult
Infectious Diseases: Pneumonia in Children and Adults Time: 11:00
a.m. – 1:00 p.m. CIV-177 – Efficacy of Lefamulin (LEF)
versus Moxifloxacin (MOX) by Pathogen in Adults with
Community-Acquired Bacterial Pneumonia (CABP): Pooled Results from
the LEAP 1 and LEAP 2 Phase 3 Clinical Trials
The abstracts can be accessed through the ASM Microbe 2019
website. Following the meeting, the posters will be available on
the Nabriva website.
About Nabriva Therapeutics
plc
Nabriva Therapeutics is a biopharmaceutical
company engaged in the development of innovative anti-infective
agents to treat serious infections. Nabriva Therapeutics has two
product candidates that are in late stage development: lefamulin,
potentially the first systemic pleuromutilin antibiotic for CABP
and CONTEPO (fosfomycin) for injection, a potential first-in-class
epoxide antibiotic in the United States for complicated urinary
tract infections (cUTIs) including acute pyelonephritis (AP). For
more information, please visit https://www.nabriva.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 Nabriva Therapeutics’
plans for further interactions with the FDA; the development of
Nabriva Therapeutics’ product candidates, such as the future
development or commercialization of lefamulin and CONTEPO, the
clinical utility of lefamulin for CABP and of CONTEPO for cUTI,
plans for and timing of the review of regulatory filings, efforts
to bring lefamulin and CONTEPO to market, the market opportunity
for and the potential market acceptance of lefamulin for CABP and
CONTEPO for cUTI, the potential benefits under its license
agreement with Sinovant Sciences, the development of lefamulin and
CONTEPO for additional indications, the development of additional
formulations of lefamulin and CONTEPO, plans to pursue research and
development of other product candidates, its ability to achieve any
of the specified regulatory or performance milestones under its
loan agreement with Hercules Capital, 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 resolve the matters set forth in the Complete Response Letter it
received from the FDA in connection with its NDA for CONTEPO
(fosfomycin) for injection; Nabriva Therapeutics’ reliance on
third-party manufacturers to manufacture the clinical and
commercial supply of its product candidates and the ability of such
third parties to comply with applicable regulatory requirements;
the content and timing of decisions made by the U.S. Food and Drug
Administration and other regulatory authorities, Nabriva
Therapeutics’ ability to realize the anticipated benefits,
synergies and growth prospects of its acquisition of Zavante
Therapeutics, 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, whether results of ZEUS will
be indicative of results for any ongoing or future clinical trials
and studies of CONTEPO, 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 CABP and CONTEPO for the treatment of cUTI, 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 InvestorsDave GarrettNabriva Therapeutics
plcdavid.garrett@nabriva.com 610-816-6657
For MediaMike BeyerSam Brown Inc.
mikebeyer@sambrown.com312-961-2502
Nabriva Therapeutics (NASDAQ:NBRV)
Historical Stock Chart
From Aug 2024 to Sep 2024
Nabriva Therapeutics (NASDAQ:NBRV)
Historical Stock Chart
From Sep 2023 to Sep 2024