TIDMMTFB
RNS Number : 9445B
Motif Bio PLC
16 January 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Receives Award from Cystic Fibrosis Foundation
Motif Bio(R) plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that the Company has received an award
from the Cystic Fibrosis Foundation to fund important in vitro
testing that will help to advance the development of iclaprim for
the treatment of lung infections in patients with cystic fibrosis
(CF). This is the first award that the Company has received from
the Cystic Fibrosis Foundation.
David Huang, MD, PhD, Chief Medical Officer of Motif Bio, said:
"We are delighted to have received this award from the Cystic
Fibrosis Foundation, a leader in the search for a cure for cystic
fibrosis. Patients with cystic fibrosis, especially in the later
stages of lung disease, are often infected with multidrug resistant
bacteria that severely limit treatment options. The grant will
advance the work we are doing to further elucidate iclaprim's
ability to inhibit the most problematic bacteria, including
multidrug resistant bacteria, that are common in patients with
cystic fibrosis."
Bacterial pathogens that infect the airways of people with CF
often exhibit broad-spectrum resistance to currently available
antibiotics. Many of these bacteria are inherently resistant to
specific classes of antibiotics. Side effects such as
nephrotoxicity and peripheral neuropathy have been reported with
currently available Gram-positive antibiotics used to treat lung
infections in patients with CF. In the in vitro study to be
conducted with the $120,000 award from the Cystic Fibrosis
Foundation, the activity of iclaprim against various strains of
Burkholderia, Stenotrophomonas and Achromobacter will be
determined. These bacteria are frequently present in the airways of
patients with CF and many strains are resistant to common
antibiotics.
Iclaprim has been studied in an animal model of chronic
pulmonary methicillin resistant Staphylococcus aureus (MRSA)
infection, which mimics the pathophysiology observed in the lungs
of patients with CF. These data were published in December 2017 in
the European Journal of Clinical Microbiology & Infectious
Diseases (Huang, D.B., Morrissey, I., Murphy, T. et al. Eur J Clin
Microbiol Infect Dis (2017).
https://doi.org/10.1007/s10096-017-3159-5). Iclaprim has been
granted orphan drug designation by the U.S. FDA for the treatment
of Staphylococcus aureus lung infections in patients with CF.
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Robert Dickey IV (Chief Financial
Officer)
+ 44 (0)20 7418
Peel Hunt LLP (NOMAD & BROKER) 8900
Dr Christopher Golden
Oliver Jackson
Northland Capital Partners +44 (0)203 861
Limited (BROKER) 6625
David Hignell/John Howes/
Rob Rees
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
Notes 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
1,300 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 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 US 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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