TIDMMTFB
Motif Bio PLC
21 February 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio to Present Iclaprim Data at ECCMID 2018
-- Phase 3 trial results for REVIVE-2 in patients with ABSSSI
-- Potential cost savings opportunities with iclaprim versus vancomycin
-- Iclaprim in vitro susceptibility data
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announces that three iclaprim abstracts have been
accepted for presentation at the upcoming 28(th) European Congress
of Clinical Microbiology and Infectious Diseases (ECCMID 2018) to
be held in Madrid, Spain, April 21-24, 2018.
ECCMID brings together leading experts in the infectious
diseases, infection control and clinical microbiology sector to
present and discuss the latest results. It is an important arena to
showcase Motif Bio's iclaprim data.
The title and description of each poster and presentation times
are noted below:
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.
Abstract: 286
Session type: Mini oral flash session
Session: Snapshot on pre-registration clinical trials
Date and Time: April 22, 2018, 11:30 AM-12:30 PM
2. Potential cost savings opportunities with targeted iclaprim
(ICL) compared to vancomycin (VAN) among hospitalized patients with
acute bacterial skin and skin structure infectious due to potential
avoidance of VAN-associated acute kidney injury
Abstract: 1290
Session type: Paper poster
Session: Clinical trial experience - new antibacterial
agents
Date and Time: April 21, 2018, 3:30-4:30 PM
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
Abstract: 204
Session type: Paper poster
Session name: Resistance in various Gram-positives
Date and time: April 23, 2018, 1:30-2:30 PM
Additionally, an abstract on results from a study amongst
Veteran's Affairs patients related to vancomycin-associated acute
kidney injury in patients hospitalised with ABSSSI will be
presented by Tom Lodise, Ph.D., PharmD and colleagues, Albany
College of Pharmacy and Health Sciences:
4. Frequency of vancomycin-associated acute kidney injury and
healthcare utilization among Veterans' Affairs patients with skin
and skin structure infections
Abstract: 1287
Session type: ePoster viewing
Session: Various bacterial infections
Date and Time: April 21-24, 2018, 8:45 AM-3:30 PM
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Walbrook PR Ltd. (UK +44 (0) 20 7933 8780 /
FINANCIAL PR & IR) motifbio@walbrookpr.com
Paul McManus/Helen Cresswell/Lianne
Cawthorne
+49 (0)89 210
MC Services AG (EUROPEAN IR) 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
The Trout Group (US IR) +1 (646 )378-2963
Meggie Purcell mpurcell@troutgroup.com
+1 (858) 717-2310
Russo Partners (US PR) +1 (212)845-4272
David Schull david.schull@russopartnersllc.com
Travis Kruse, Ph.D. travis.kruse@russopartnersllc.com
Note to Editors:
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. The first proposed indication, and near-term
commercial opportunity, is for the treatment of ABSSSI, 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 current standard of care antibiotics, in clinical
trials to date, nephrotoxicity has not been observed with iclaprim
and dosage adjustment has not been required in patients with renal
impairment.
Iclaprim has an underutilised mechanism of action compared to
other antibiotics. 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. Additionally, data support that
the inactive metabolites of iclaprim clear through the kidneys. 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 May 1, 2017, 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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February 21, 2018 02:01 ET (07:01 GMT)
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