TIDMMTFB
Motif Bio PLC
06 October 2017
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Presents New Pre-Clinical Data for Iclaprim at IDWeek
2017(TM)
1. Pre-Clinical Data Support the Potential Use of Iclaprim in
the Treatment of Staphylococcus aureus Pneumonia in Cystic Fibrosis
Patients
2. Iclaprim Demonstrates Potent In Vitro Suppression of
Exotoxins in MRSA Isolates
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical stage
biopharmaceutical company specialising in developing novel
antibiotics, announced that new pre-clinical data with its
investigational drug candidate iclaprim were presented today during
the IDWeek 2017(TM) conference, held in San Diego, CA, 4-8 October
2017.
Efficacy Evaluation of Iclaprim in a Neutropenic Rat Lung
Infection Model with Methicillin-Resistant Staphylococcus aureus
Entrapped in Alginate Microspheres (Poster #1525)
David Huang, M.D., Ph.D., Chief Medical Officer of Motif Bio,
presented data from an in vivo study evaluating the therapeutic
potential of iclaprim in methicillin-resistant Staphylococcus
aureus (MRSA) lung infections. In an in vivo model mimicking the
pathophysiology observed in patients with cystic fibrosis, rats
received either iclaprim 80 mg/kg (n=16), iclaprim 60 mg/kg (n=16),
vancomycin 50 mg/kg (n=24) or placebo (n=29). Regardless of dose,
the iclaprim-treated rats demonstrated 100% survival (33/33), while
the vancomycin group demonstrated 91.7% survival (22/24) and the
control group showed 48.3% survival (14/29). In addition to the
improved survival rates, iclaprim treatment resulted in a
significantly greater reduction in bacterial colony forming units
(CFUs) compared to vancomycin (iclaprim 80 mg/kg vs vancomycin:
p=0.0002; iclaprim 60 mg/kg vs vancomycin: p=0.05). The poster is
available on the IDWeek website at this link.
Dr Huang commented: "Following the recently announced positive,
top-line Phase 3 REVIVE-2 clinical trial results for iclaprim for
acute bacterial skin and skin structure infections (ABSSSI), the
data presented today at IDWeek underscore the potential utility of
iclaprim in a range of patient populations with suspected MRSA
infections, including cystic fibrosis patients with Staphylococcus
aureus lung infections. Staphylococcus aureus is a common cause of
pneumonia in patients with cystic fibrosis and we do not believe
that any antibiotic has been approved for this indication. Some 80%
or more of patients with cystic fibrosis die as a result of
respiratory infections caused by a variety of bacteria, and MRSA
infections have been growing in recent years. The encouraging new
data presented today support developing iclaprim as a potential
treatment option for MRSA infections in patients with cystic
fibrosis, and iclaprim was recently granted Orphan Drug Designation
in the U.S. for Staphylococcus aureus lung infections in this
patient group."
Effects of Iclaprim and Trimethoprim on Exotoxin Production by
Methicillin-Resistant Staphylococcus aureus (Poster #1219)
Amy Bryant, PhD, VA Medical Center, Boise, ID presented data
from an in vitro study evaluating the effects of sub-inhibitory
doses of dihydrofolate reductase inhibitors (iclaprim and
trimethoprim), compared to cell wall-active agents (nafcillin,
vancomycin) on the exotoxin production from two clinical MRSA
isolates. Exotoxins such as alpha-hemolysin (AH) and Toxic shock
syndrome toxin 1 (TSST-1) mediate the development of disease, and
inhibition of toxin production is an important consideration in
choosing appropriate treatments for MRSA infections. Vancomycin is
recommended for severe MRSA infections; however, increasing
vancomycin resistance, poor clinical outcomes and kidney toxicity
are serious concerns. The results, showed that iclaprim and
trimethoprim delayed the onset of mRNA production, suppressed AH
production, and delayed maximal TSST-1 in two community-acquired
MRSA strains. The poster is available on the IDWeek website at this
link.
Dr. Huang said: "Toxin suppression is an important therapeutic
goal for severe infections due to toxin-producing Gram-positive
pathogens such as MRSA. The in vitro data presented show that
Iclaprim, at concentrations below those that inhibit bacterial
growth, suppress toxin production. Iclaprim is 15-fold more active
than trimethoprim, supporting the use of iclaprim to treat serious
MRSA infections in hospitalised patients."
For further information, please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Robert Dickey IV (Chief Financial
Officer)
Walbrook PR Ltd. (UK +44(02079338780 /motifbio@walbrookpr.com
FINANCIAL PR & IR)
Paul McManus Mob: +44 (0)7980
541 893
Mike Wort Mob: +44 (0)7900
608 002
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
The Trout Group (US IR) +1 (646 )378-2938
Michael Gibralter mgibralter@troutgroup.com
Lazar Partners (US PR) motiflp@lazarpartners.com
Chantal Beaudry +1 (646) 871-8480
Amy Wheeler +1 (646) 871-8486
Notes to Editors
IDWeek 2017(TM)
IDWeek 2017(TM) is the combined annual meeting of the Infectious
Diseases Society of America (IDSA), the Society for Healthcare
Epidemiology of America (SHEA), the HIV Medicine Association
(HIVMA), and the Pediatric Infectious Diseases Society (PIDS). The
annual meeting is attended by more than 6,000 healthcare
professionals practicing or involved in infectious diseases and
healthcare epidemiology and prevention, including researchers,
clinicians, quality and patient safety practitioners, and
epidemiologists. It is a recognized forum for peer-reviewed
presentations of new research on scientific advances and
bench-to-bedside approaches in prevention, diagnosis, treatment,
and epidemiology of infectious diseases, including HIV, across the
lifespan.
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
1,300 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. The first proposed indication, and near-term
commercial opportunity, is for the treatment of acute bacterial
skin and skin structure infections (ABSSSI), one of the most common
bacterial infections, with 3.6 million patients hospitalised
annually in the US. 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 chronic pulmonary MRSA infection which mimics
the pathophysiology observed in patients with cystic fibrosis.
Results from this study were presented at IDWeek 2017(TM) on 6
October 2017 in San Diego, CA. 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 data 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 plc'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 plc
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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