TIDMMTFB
Motif Bio PLC
08 May 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio to Present Iclaprim Data at ASM Microbe 2018
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that two iclaprim abstracts have been
accepted for presentation at the upcoming American Society For
Microbiology (ASM) Microbe 2018 meeting to be held in Atlanta, GA,
USA, June 7-11, 2018. The abstracts are now available online on the
ASM website.
ASM Microbe showcases the best microbial sciences in the world
and provides a forum to explore the complete spectrum of
microbiology from basic science to translation and application.
1. An Analysis of Pooled Efficacy Data from Two Phase 3 Trials
of Iclaprim Compared to Vancomycin for the Treatment of Acute
Bacterial Skin and Skin Structure Infections
Poster number: 640
Session type: Poster session
Session: Pharmacological Studies of Antimicrobial Agents Pre-NDA
(Phase 2/3): New Agents between Phase 2 and FDA Approval
Date and Time: June 9, 2018, 11:00 AM-1:00 PM
A link to the abstract can be found here.
2. A Pooled Analysis of Two Phase 3, Randomized, Double-Blind,
Multicenter Studies to Evaluate the Safety of Intravenous Iclaprim
versus Vancomycin
Poster number: 641
Session type: Poster session
Session: Pharmacological Studies of Antimicrobial Agents Pre-NDA
(Phase 2/3): New Agents between Phase 2 and FDA Approval
Date and Time: June 9, 2018, 11:00 AM-1:00 PM
A link to the abstract can be found here.
For further information please contact:
Motif Bio plc info@motifbio.com
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 IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
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. 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. To date, iclaprim has been
studied in over 1,400 patients and healthy volunteers. Clinical and
microbiological data indicate that iclaprim has a targeted
Gram-positive spectrum of activity, low propensity for resistance
development and favourable tolerability profile. 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. Many standard of care Gram-positive
antibiotics are not suitable for patients with renal impairment due
to efficacy and/or safety issues. No kidney toxicity was observed
with iclaprim in the REVIVE Phase 3 trials.
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage
biopharmaceutical company focused on developing novel antibiotics
for hospitalised patients and designed to be effective against
serious and life-threatening infections caused by multi-drug
resistant bacteria, including MRSA. The Company's lead product
candidate is iclaprim. Following positive results from two Phase 3
trials (REVIVE-1 and REVIVE-2), a rolling submission of an NDA with
the U.S. FDA for the treatment of 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.
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 in patients with HABP
has been successfully completed and a Phase 3 trial is being
planned. Additionally, iclaprim has been granted orphan drug
designation by the FDA for the treatment of Staphylococcus aureus
lung infections in patients with cystic fibrosis and is in
preclinical development for this indication..
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track status.
Upon acceptance by the FDA of an 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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May 08, 2018 02:01 ET (06:01 GMT)
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