Motif Bio PLC Orphan Disease Opportunity for Iclaprim
22 Maggio 2019 - 8:01AM
RNS Non-Regulatory
TIDMMTFB
Motif Bio PLC
22 May 2019
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio to Evaluate Orphan Disease Opportunity for Iclaprim in
Ophthalmology
Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that the Company has signed an
agreement with Otto-von-Guericke University Magdeburg to conduct a
study evaluating iclaprim in an in vitro model of ocular
toxoplasmosis. The research will focus on toxoplasma
chorioretinitis, an orphan disease that is a type of ocular
toxoplasmosis, a parasitic disease that may result in severe
life-threatening infections and/or blindness. The work will be led
by Prof. Dr. Ildiko Rita Dunay, Director, Institute of Inflammation
and Neurodegeneration at the university.
Dr. David Huang, Chief Medical Officer of Motif Bio, said: "We
are very pleased to work with Dr. Dunay, who is an expert in the
area of toxoplasmosis. In vitro data indicate that iclaprim has
activity against toxoplasma. The data generated from Dr. Dunay's
lab will be important in understanding whether iclaprim can play a
role in this potentially devastating, progressive and recurring
necrotizing retinitis, including vision-threatening
complications."
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/Lianne Cawthorne/Helen motifbio@walbrookpr.com
Cresswell
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
LifeSci Advisors (U.S. IR) +1 (646) 597 6989
Bob Yedid bob@lifesciadvisors.com
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 pre-clinical development for this
indication.
Iclaprim 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 15, 2019, 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.
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END
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