Motif Bio PLC Data Confirming Standard Clinical Trial Dosage (8019N)
31 Ottobre 2016 - 8:00AM
UK Regulatory
TIDMMTFB
RNS Number : 8019N
Motif Bio PLC
31 October 2016
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART
DIRECTLY OR INDIRECTLY IN, INTO OR FROM ANY JURISDICTION WHERE TO
DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR
REGULATIONS OF SUCH JURISDICTION
This announcement contains inside information.
Motif Bio plc
("Motif Bio" or the "Company")
Data supporting optimized Iclaprim dosing in REVIVE trial
presented at IDWeek 2016
Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical
company specialising in developing novel antibiotics, announces
that data were presented at IDWeek 2016 in New Orleans supporting
the fixed dose of iclaprim designed to optimize efficacy and safety
outcomes in the Company's ongoing Phase 3 REVIVE clinical
trials.
Using the pharmacokinetic/pharmacodynamics (PK/PD) data
collected from 470 patients enrolled in the previously conducted
Phase 3 cSSSIs trials (ASSIST-1 and -2), population PK modeling was
used to identify an optimal fixed dose regimen.
Iclaprim administered as an 80 mg infusion over two hours
provided a 28% increase in AUC/MIC and a 32% increase in the T >
MIC compared to the dosing regimen used in the ASSIST trials. This
dosing regimen maintains the effective level of iclaprim for
longer, while reducing the peak concentration, a property that has
been associated with adverse effects. The iclaprim fixed dose may
help reduce the resources required in hospitals since dosage
adjustment by health care professionals is avoided, and overall
hospital treatment costs may be lower, especially in renally
impaired patients.
The full poster can be downloaded at:
https://idsa.confex.com/idsa/2016/webprogram/Paper56639.html
A registration statement relating to the Company's securities
has been filed with the SEC, but has not yet become effective. Such
securities may not be sold, nor may offers to buy the securities be
accepted, prior to the time the registration statement becomes
effective. This press release shall not constitute an offer to sell
or a solicitation of an offer to buy any securities, nor shall
there be any sale of these securities in any state or jurisdiction
in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any
such state or jurisdiction.
Forward-looking statements
This news release contains forward-looking statements that
reflect Motif Bio's current expectations regarding future events,
including statements regarding the potential clinical benefits and
commercial potential of iclaprim. Forward-looking statements
involve risks and uncertainties. Actual events could differ
materially from those projected herein and depend on a number of
factors, including (inter alia), the success of Motif Bio's
clinical development strategies, the successful and timely
completion of uncertainties related to the regulatory process, and
the acceptance of iclaprim and other products by consumer and
medical professionals. A further list and description of risks and
uncertainties associated with an investment in Motif Bio can be
found in Motif Bio's filings with the U.S. Securities and Exchange
Commission. Existing and prospective investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Motif Bio undertakes no
obligation to update or revise the information contained in this
press release, whether as a result of new information, future
events or circumstances or otherwise.
For further information please contact:
Motif Bio plc info@motifbio.com
Richard Morgan (Chairman)
Graham Lumsden (Chief
Executive Officer)
Zeus Capital Limited
(NOMAD & BROKER)
Phil Walker/Giles Balleny
Dominic Wilson +44 (0)20 3829 5000
Northland Capital Partners
Limited (BROKER)
Patrick Claridge/ David
Hignell
John Howes/ Rob Rees
(Broking) +44 (0)20 3861 6625
Walbrook PR Ltd. (FINANCIAL +44 (0)20 7933 8780 or motifbio@walbrookpr.com
PR & 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
Motif Bio is a clinical-stage biopharmaceutical company, engaged
in the research and development of novel antibiotics designed to be
effective against serious and life-threatening infections in
hospitalized patients caused by multi-drug resistant bacteria. Our
lead product candidate, iclaprim, is being developed for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI) and hospital acquired bacterial pneumonia (HABP),
including ventilator associated bacterial pneumonia (VABP), which
is often caused by MRSA (methicillin resistant Staphylococcus
aureus). We are currently enrolling and dosing patients in two
global Phase 3 clinical trials (Revive 1 and Revive 2) with an
intravenous formulation of iclaprim, for the treatment of ABSSSI.
Data readout for REVIVE-1 is expected in the second quarter of 2017
and REVIVE-2 is on track for data readout in the second half of
2017.
This information is provided by RNS
The company news service from the London Stock Exchange
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