Motif Bio Receives Award from Cystic Fibrosis Foundation
16 January 2018 - 6:00PM
Motif Bio® plc (AIM:MTFB) (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) |
|
|
|
Peel Hunt LLP (NOMAD & BROKER) |
+ 44 (0)20 7418 8900 |
Dr
Christopher Golden |
|
Oliver
Jackson |
|
|
|
Northland Capital Partners Limited (BROKER) |
+44
(0)203 861 6625 |
David
Hignell/John Howes/ Rob Rees |
|
|
|
Walbrook PR
Ltd. (UK FINANCIAL PR & IR) |
+44 (0) 20 7933 8780 / motifbio@walbrookpr.com |
Paul
McManus/Helen Cresswell/Lianne Cawthorne |
|
|
|
MC
Services AG (EUROPEAN IR) |
+49
(0)89 210 2280 |
Raimund
Gabriel |
raimund.gabriel@mc-services.eu |
|
|
The
Trout Group (US IR) |
+1 (646
)378-2963 |
Meggie
Purcell |
mpurcell@troutgroup.com |
|
|
Russo Partners (US PR) |
+1
(858) 717-2310 |
|
+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:MTFB) (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.
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