TIDMMTFB
Motif Bio PLC
11 April 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Announces Iclaprim Abstracts for ECCMID 2018 Now
Online
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announces that iclaprim-related abstracts are now
online for the upcoming 28(th) European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID 2018) to be held in
Madrid, Spain, April 21-24, 2018.
The abstracts are as follows:
1. A phase-3, randomized, double-blind, multicentre study to
evaluate the safety and efficacy of intravenous iclaprim versus
vancomycin in the treatment of acute bacterial skin and skin
structure infections suspected or confirmed to be due to
Gram-positive bacteria (REVIVE-2).
2. Potential cost savings opportunities with targeted iclaprim
compared to vancomycin among hospitalized patients with acute
bacterial skin and skin structure infectious due to potential
avoidance of vancomycin-associated acute kidney injury
3. Surveillance of iclaprim activity: in vitro susceptibility of
Staphylococcus aureus resistant to clindamycin/tetracycline and
beta-haemolytic streptococci resistant to macrolides/ tetracyclines
in skin and skin-structure pathogens collected during 2015-2016
The abstracts can be found here.
Additionally, an abstract, Frequency of vancomycin-associated
acute kidney injury and healthcare utilization among Veterans'
Affairs patients with skin and skin structure infections, being
presented by Thomas Lodise, Ph.D., PharmD and colleagues, Albany
College of Pharmacy and Health Sciences, is now available online at
this link.
For further information please contact:
Motif Bio plc info@motifbio.com
Dr. Graham Lumsden (Chief
Executive Officer)
Walbrook PR Ltd. (UK FINANCIAL
PR & IR) +44 (0) 20 7933 8780
Paul McManus/Helen Cresswell/Lianne
Cawthorne
MC Services AG (EUROPEAN raimund.gabriel@mc-services.eu
IR)
Raimund Gabriel +49 (0)89 210 2280
Solebury Trout (US IR) + 1 (646) 378-2936
Meggie Purcell mpurcell@troutgroup.com
Russo Partners (US PR) +1 (858) 717-2310 or
+1 (212) 845 4272
David Schull david.schull@russopartnersllc.com
Travis Kruse, Ph.D. travis.kruse@russopartnersllc.com
Note to Editors:
About Iclaprim
Iclaprim is a novel investigational antibiotic that has a
different and underutilised mechanism of action compared to other
antibiotics. Iclaprim exhibits potent in vitro activity against
Gram-positive clinical isolates of many genera of staphylococci,
including methicillin-resistant Staphylococcus aureus (MRSA).
Iclaprim is rapidly bactericidal, achieving 99.9% in vitro kill
against MRSA within 4 to 6 hours of drug exposure versus 8 to 10
hours for vancomycin. To date, iclaprim has been studied in over
1,400 patients and healthy volunteers. In clinical studies iclaprim
has been administered intravenously at a fixed dose with no dosage
adjustment required in patients with renal impairment or in obese
patients. The iclaprim fixed dose may, if approved, 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 patients with renal impairment.
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) 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 hospitalised patients caused by
multi-drug resistant bacteria, including MRSA. The Company's lead
product candidate, iclaprim, is being developed for high-risk MRSA
patient populations. Following positive results from two Phase 3
trials (REVIVE-1 and REVIVE-2), a rolling submission of a New Drug
Application (NDA) with the U.S. Food & Drug Administration
(FDA) for the treatment of acute bacterial skin and skin structure
infections (ABSSSI) has been initiated and is expected to be
completed in the second quarter of 2018. ABSSSI is one of the most
common bacterial infections, with 3.6 million patients hospitalised
annually in the U.S. The Company believes that iclaprim may be
suitable for first-line empiric therapy in ABSSSI patients,
especially those with renal impairment, with or without diabetes.
Unlike many standard of care antibiotics, iclaprim is only
minimally cleared via the kidneys (<2% of the administered dose
was recovered unchanged in the urine). No nephrotoxicity was
observed with iclaprim in the REVIVE Phase 3 trials and dosage
adjustment has not been required in patients with renal
impairment.
Clinical and microbiology data indicate iclaprim has a targeted
Gram-positive spectrum of activity, low propensity for resistance
development, fixed dose administration and favourable tolerability
profile. The Company also 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 was
conducted to study iclaprim in patients with HABP. Iclaprim has
been studied in an animal model of pulmonary MRSA infection which
mimics the pathophysiology observed in patients with cystic
fibrosis. Iclaprim has been granted orphan drug designation by the
U.S. FDA for the treatment of Staphylococcus aureus lung infections
in patients with cystic fibrosis.
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track status.
Upon acceptance by the FDA of a New Drug Application (NDA),
iclaprim will receive Priority Review status and, if approved as a
New Chemical Entity, 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.
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, and (x) 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 10, 2018,
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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April 11, 2018 09:30 ET (13:30 GMT)
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