Motif Bio PLC Receipt of FDA Concurrence (6961G)
24 Novembre 2015 - 8:01AM
UK Regulatory
TIDMMTFB
RNS Number : 6961G
Motif Bio PLC
24 November 2015
24 November 2015
Motif Bio plc
("Motif" or the "Company")
Receipt of FDA Concurrence with Optimized Dose for Iclaprim
Phase III Clinical Trials
Motif Bio plc (AIM:MTFB), the clinical stage biopharmaceutical
company specialising in developing novel antibiotics, announced
today that it has received written concurrence from the United
States Food and Drug Administration ("FDA") for an optimized fixed
dose of iclaprim of 80mg for all patients except those with
moderate hepatic impairment, regardless of bodyweight, in the
Company's proposed Phase III clinical trials for the treatment of
acute bacterial skin and skin structure infections ("ABSSSI"). The
fixed dose of iclaprim, together with the selected infusion time,
optimizes pharmacodynamic parameters associated with antibacterial
efficacy, while potentially minimizing safety events.
Iclaprim, a targeted spectrum antibiotic designed to be
effective against multi-drug-resistant bacteria, including MRSA,
will be tested in randomised, double blind, multicentre clinical
trials to evaluate the efficacy and safety of intravenous iclaprim
versus intravenous vancomycin in the treatment of ABSSSI. The
iclaprim fixed dose regime can help reduce the time required for
dosage adjustment or monitoring by healthcare professionals in
renally impaired or obese patients, leading to reduced overall
hospital treatment costs in these high risk patient populations.
Studies have found that hospitalized patients with ABSSSI have a
higher occurrence of obesity and renal impairment than in the
general adult population. Obesity can affect the pharmacokinetics
and pharmacodynamics of many drugs, including antimicrobial
therapies, potentially leading to suboptimal drug concentrations in
serum or tissue. Obese patients have been found to be at risk for
clinical failure following inadequate dosing of antimicrobial
therapy.
Dr. David Huang, Chief Medical Officer at Motif, said:
"Concurrence from the FDA of the potential efficacy and safety
benefits of this fixed dose regime is important for the iclaprim
Phase III trials and, assuming approval, will offer clear benefits
for practitioners and patients. The fixed dose regime should save
significant time treating high risk patients where a rapid response
is critical."
For further information please contact
Enquiries:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
David Huang (Chief Medical Officer)
www.motifbio.com
Zeus Capital Limited (NOMINATED
ADVISER and BROKER)
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(BROKER)
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John Howes/ Mark Treharne (Broking) 7382 1100
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MC Services AG (TRADE PR) 210 2280
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PR)
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Dominic Barretto 788 221
Notes to Editors:
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 2017 and if approved, iclaprim could be
ready for commercialization in 2018. The Company is in discussions
with pharmaceutical companies and universities to build a pipeline
of innovative antibiotics targeting Gram-positive and Gram-negative
bacteria. For additional information about Motif please visit
www.motifbio.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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