Motif Bio PLC First patient dosed in iclaprim Phase 3 trials (7055Q)
02 Marzo 2016 - 8:00AM
UK Regulatory
TIDMMTFB
RNS Number : 7055Q
Motif Bio PLC
02 March 2016
Motif Bio plc
("Motif" or the "Company")
First patient dosed in iclaprim Phase 3 trials to treat skin
infections
Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical
company specialising in developing novel antibiotics, announces the
dosing of the first patient in two Phase 3 clinical trials of its
lead antibiotic candidate iclaprim, for the treatment of acute
bacterial skin and skin structure infections (ABSSSIs).
The REVIVE (Randomized Evaluation IntraVenous Iclaprim
Vancomycin TrEatment) clinical trials will assess the efficacy and
safety of iclaprim compared to a standard of care antibiotic,
vancomycin, for the treatment of ABSSSIs. The two trials will be
run by Covance and are global, multicentre, randomised,
double-blind, Phase 3 studies evaluating a total of 1,200 adult
patients who are hospitalised with ABSSSIs. The primary endpoint
for the studies will be at least a 20 per cent reduction in lesion
size at 48 to 72 hours after treatment. The key secondary endpoint
is clinical cure at one to two weeks after treatment.
The successful completion of these two pivotal Phase 3 trials
would satisfy both FDA and EMA requirements for regulatory
approval. With the dosing of the first patient underway, both
ABSSSI trials are expected to be completed in 2H17.
ABSSSI is a serious and life threatening infection caused by
multi-drug resistant bacteria. The Phase 3 programme is designed to
obtain marketing approval for an intravenous formulation of
iclaprim for the treatment of ABSSSI.
Graham Lumsden, CEO of Motif Bio, stated: "This is an important
milestone for Motif that keeps us on track to complete the trials
in the second half 2017. Iclaprim has the potential to be a major
addition to the armamentarium of antibiotics much needed for the
treatment of serious and life-threatening infections caused by
multi-drug resistant bacteria in hospitalised patients."
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
David Huang (Chief Medical Officer)
Zeus Capital Limited (NOMAD &
BROKER)
Phil Walker/Dan Bate
Dominic Wilson +44 (0)20 3829 5000
Northland Capital Partners Limited
(BROKER)
Patrick Claridge/ David Hignell
John Howes/ Rob Rees (Broking) +44 (0)20 7382 1100
Walbrook PR Ltd. (FINANCIAL PR +44 (0)20 7933 8780 or motifbio@walbrookpr.com
& IR) Mob: +44 (0)7980 541 893
Paul McManus Mob: +44 (0)7900 608 002
Mike Wort
MC Services AG (EUROPEAN IR)
Raimund Gabriel +49 (0)89 210 2280
About Motif Bio (www.motifbio.com)
Motif is a clinical-stage biopharmaceutical company,
specialising in the development of novel antibiotics that are
designed to be effective against serious and life-threatening
infections caused by multi-drug resistant bacteria. Our lead
product candidate, 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). Two Phase III ABSSSI clinical trials are on
track to be completed in 2H17 and if approved, iclaprim could be
ready for commercialisation in 2018. The HABP trial is expected to
start 2H16.
The Company is in discussions with pharmaceutical companies and
universities to build a pipeline of innovative antibiotics
targeting Gram-positive and Gram-negative bacteria.
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCEAPDFEEPKEFF
(END) Dow Jones Newswires
March 02, 2016 02:00 ET (07:00 GMT)
Grafico Azioni Motif Bio (LSE:MTFB)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni Motif Bio (LSE:MTFB)
Storico
Da Lug 2023 a Lug 2024