TIDMMTFB
RNS Number : 9214Q
Motif Bio PLC
15 September 2017
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio announces iclaprim granted Orphan Drug Designation by
US FDA
for treatment of Staphylococcus aureus lung infections in
patients with cystic fibrosis
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical stage
biopharmaceutical company specialising in developing novel
antibiotics, announced today that the US Food and Drug
Administration ("FDA") has granted its investigational drug
candidate, iclaprim, Orphan Drug Designation for the treatment of
Staphylococcus aureus lung infections in patients with cystic
fibrosis.
Orphan designation grants special status to a drug or biologic
under development to treat a rare disease or condition and
qualifies the sponsor of the product for various development
incentives, including tax credits for qualified clinical testing,
waiver of user fees and potentially up to seven years of market
exclusivity for the given indication, if approved.
"Staphylococcus aureus, including MRSA, is one of the common
causes of lung infections 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,"
said Graham Lumsden, Chief Executive Officer of Motif Bio.
"Formulation development work is underway at Motif Bio to explore
potential intravenous and inhaled formulations designed
specifically for cystic fibrosis patients."
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 cystic fibrosis. These data will be presented at
IDWeek on October 6, 2017 in San Diego, CA.
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
Patrick Claridge/ David Hignell
John Howes/ Rob Rees (Broking)
Walbrook PR Ltd. (UK +44 (0) 20 7933 8780 /
FINANCIAL PR & IR) motifbio@walbrookpr.com
Paul McManus Mob: +44 (0)7980
541 893
Mike Wort Mob: +44 (0)7900
608 002
+49 (0)89 210
MC Services AG (EUROPEAN IR) 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
The Trout Group (US IR) +1 (646 )378-2938
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
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 will be presented at IDWeek on October 6,
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 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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