TIDMMTFB
Motif Bio PLC
04 April 2019
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio to Present Iclaprim Data at ECCMID 2019
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announced today that four iclaprim abstracts have been
accepted for presentation at the upcoming 28(th) European Congress
of Clinical Microbiology and Infectious Diseases (ECCMID 2019) to
be held in Amsterdam, The Netherlands, April 13-16, 2019.
ECCMID brings together leading experts in the infectious
diseases, infection control and clinical microbiology sector to
present and discuss the latest results.
Details for each presentation and poster are noted below,
including links to the related abstracts, which are available at
https://www.eccmidlive.org.
1. An efficacy analysis by lesion size of iclaprim versus
vancomycin in patients with acute bacterial skin and skin structure
infections: pooled phase III REVIVE trials (#O0303)
Session type: Mini oral e-poster session
Session: Clinical trials with recently approved or late-stage
development antibiotics
Date and Time: April 13, 2019, 2:45-3:45 PM
The link to the abstract is available here.
2. Surveillance of iclaprim activity against Gram-positive
cocci, including antibiotic-resistant strains, collected from
patients with skin and skin structure infections during 2017 from
European and American hospitals (#P1884)
Session type: Paper poster
Session name: In vitro activity of newer antibacterial
agents
Date and time: April 15, 2019, 1:30-2:30 PM
The link to the abstract is available here.
3. Iclaprim versus vancomycin for patients with acute bacterial
skin and skin structure infection complicated by Staphylococcus
aureus or streptococcal bacteraemia: a pooled analysis of the phase
III REVIVE trials (#P2287)
Session type: Paper poster
Session name: Skin and soft tissue infections
Date and time: April 16, 2019, 12:30-1:30 PM
The link to the abstract is available here.
4. Pharmacokinetics of iclaprim by age, weight, race and
renal/hepatic function in patients with acute bacterial skin and
skin structure infections: phase III REVIVE trials (#O1162)
Session type: Oral session
Session: PK/PD to guide dosing in special populations
Date and Time: April 16, 2019, 1:30 PM-3:30 PM
The link to the abstract is available here.
Additionally, an abstract on results from a study on the
real-world incidence of vancomycin-associated nephrotoxicity in
patients hospitalised with ABSSSI will be presented by Michael J.
Rybak, PharmD, MPH, FCCP, BCPS, Associate Dean for Research,
Professor of Pharmacy and Medicine Director, The Anti-Infective
Research Laboratory, Eugene Applebaum College of Pharmacy and
Health Science, Wayne State University:
Real-world incidence of vancomycin-associated nephrotoxicity in
hospitalised patients with acute bacterial skin and soft structure
infections (#P2297)
Session type: Paper poster
Session: Skin and soft tissue infections
Date and Time: April 16, 2019, 12:30-1:30 PM
The link to the abstract is available here.
For further information please contact:
Motif Bio plc ir@motifbio.com
Graham Lumsden (Chief Executive Officer)
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0)20 7933 8780
Paul McManus/Helen Cresswell/Lianne motifbio@walbrookpr.com
Cawthorne
MC Services AG (EUROPEAN IR) +49 (0) 89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
Russo Partners (U.S. PR) +1 (858) 717-2310 or +1 (212)
845 4272
David Schull david.schull@russopartnersllc.com
Note to Editors:
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage
biopharmaceutical company focused on developing novel antibiotics
designed to be effective against serious and life-threatening
infections caused by multi-drug resistant Gram-positive bacteria,
including MRSA. The Company's lead product candidate is iclaprim.
Motif Bio is seeking approval of iclaprim from the U.S. Food &
Drug Administration (FDA) for the treatment of acute bacterial skin
and skin structure infections (ABSSSI). More than 3.6 million
patients with ABSSSI are hospitalised annually in the U.S. It is
estimated that up to 26% of hospitalized ABSSSI patients have renal
impairment.
The Company also has plans to develop iclaprim for hospital
acquired bacterial pneumonia (HABP), including ventilator
associated bacterial pneumonia (VABP), as there is a high unmet
need for new therapies in this indication. A Phase 2 trial in
patients with HABP has been successfully completed and a Phase 3
trial is being planned. Additionally, iclaprim has been granted
orphan drug designation by the FDA for the treatment of
Staphylococcus aureus lung infections in patients with cystic
fibrosis and is in preclinical development for this indication.
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track status for
the ABSSSI indication. If approved for the ABSSSI indication as a
New Chemical Entity, iclaprim will be eligible for 10 years of
market exclusivity in the U.S. from the date of first approval,
under the Generating Antibiotic Incentives Now Act (the GAIN Act).
In Europe, 10 years of market exclusivity is anticipated. Motif is
also building a patent estate to provide additional protection for
iclaprim and has two U.S. method of use patents issued that will
expire in 2037.
Forward-Looking Statements
This press release contains forward-looking statements. Words
such as "expect," "believe," "intend," "plan," "continue," "may,"
"will," "anticipate," and similar expressions are intended to
identify forward-looking statements. Forward-looking statements
involve known and unknown risks, uncertainties and other important
factors that may cause Motif Bio's actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. Motif Bio believes that these factors
include, but are not limited to, (i) the timing, progress and the
results of clinical trials for Motif Bio's product candidates, (ii)
the timing, scope or likelihood of regulatory filings and approvals
for Motif Bio's product candidates, (iii) Motif Bio's ability to
successfully commercialise its product candidates, (iv) Motif Bio's
ability to effectively market any product candidates that receive
regulatory approval, (v) Motif Bio's commercialisation, marketing
and manufacturing capabilities and strategy, (vi) Motif Bio's
expectation regarding the safety and efficacy of its product
candidates, (vii) the potential clinical utility and benefits of
Motif Bio's product candidates, (viii) Motif Bio's ability to
advance its product candidates through various stages of
development, especially through pivotal safety and efficacy trials,
(ix) Motif Bio's estimates regarding the potential market
opportunity for its product candidates, (x) Motif Bio's ability to
raise additional capital to sustain its operations and pursue its
strategy and (xi) the factors discussed in the section entitled
"Risk Factors" in Motif Bio's Annual Report on Form 20-F filed with
the SEC on April 10, 2018, which is available on the SEC's web
site, www.sec.gov. Motif Bio undertakes no obligation to update or
revise any forward-looking statements.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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