Motif Bio PLC FDA Meeting Minutes Confirming Iclaprim Phase III
28 Maggio 2015 - 8:02AM
RNS Non-Regulatory
TIDMMTFB
Motif Bio PLC
28 May 2015
28 May 2015
Motif Bio plc.
("Motif" or the "Company")
Motif Receives FDA Meeting Minutes Confirming Iclaprim Phase III
Clinical Development Programme
Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical
company specialising in developing novel antibiotics, announced
today that it has received the official meeting minutes from the
U.S. Food and Drug Administration (FDA) guidance meeting which was
held on 14 April 2015. The minutes confirm the FDA's agreement with
Motif's Phase III clinical development programme for iclaprim, a
broad-spectrum antibiotic designed to be effective against
multi-drug resistant bacteria.
Iclaprim, a novel selective inhibitor of microbial dihydrofolate
reductase (DHFR), is being developed as an intravenous (IV)
formulation to treat acute bacterial skin and skin structure
infections (ABSSSI) and hospital acquired bacterial pneumonia
(HABP) caused by Gram positive pathogens, including resistant
strains such as methicillin-resistant Staphylococcus aureus (MRSA)
and multi-drug resistant Streptococcus pneumoniae (MDRSP). The FDA
has confirmed that two successful Phase III trials are required for
the approval of iclaprim.
Graham Lumsden, CEO of Motif Bio plc, commented:
"This FDA confirmation supports Motif moving forward to begin
the iclaprim Phase III clinical programme. The trials will
investigate the safety and efficacy of iclaprim in patients with
ABSSSI and HABP, two serious and life threatening infections caused
by multi--drug resistant bacteria. We believe that iclaprim may be
an important addition in the fight against life threatening
infections, a battle that is currently being lost to increasing
antimicrobial resistance."
Enquiries
Motif Bio plc. info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Robert Bertoldi (Chief Financial
Officer)
www.motifbio.com
+49 (0) 89
MC Services AG (TRADE PR) 210 2280
Raimund Gabriel +44 (0) 207
Shaun Brown 148 5998
Cairn Financial Advisers LLP +44 (0) 20
(NOMAD) 7148 7900
Tony Rawlinson
Carolyn Sansom
Northland Capital Partners Limited +44 (0) 20
(BROKER) 7382 1100
Gerry Beaney/David Hignell
John Howes/Mark Treharne (Broking)
Plumtree Capital Limited (FINANCIAL +44 (0) 207
ADVISOR) 183 2493
Stephen Austin
Yellow Jersey PR Limited (FINANCIAL
PR)
Dominic Barretto +44 (0) 7768
Fiona Walker 537 739
Notes to Editors:
Motif is a clinical stage biopharmaceutical company, which
specialises in developing novel antibiotics designed to be
effective against serious and life-threatening infections caused by
multi-drug resistant bacteria. The Company has a lead antibiotic
candidate, iclaprim, in clinical development and MTF-001, a
preclinical stage programme to design a best-in-class dihydrofolate
reductase inhibitor (DHFRi).
Iclaprim is being developed for the treatment of the most common
and serious bacterial infections such as acute bacterial skin and
skin structure infections (ABSSSI) and hospital acquired bacterial
pneumonia (HABP), including those caused by resistant strains such
as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP
(multi-drug resistant Streptococcus pneumoniae) that have become
prevalent in patients in both the community and hospital
settings.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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