Motif Bio announces iclaprim granted Orphan Drug Designation by US FDA for treatment of Staphylococcus aureus lung infections...
September 15 2017 - 8:35AM
Motif Bio plc (AIM:MTFB) (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: |
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Motif Bio plc |
info@motifbio.com |
Graham Lumsden (Chief Executive Officer) |
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Robert Dickey IV (Chief Financial Officer) |
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Peel Hunt LLP (NOMAD & BROKER) |
+ 44 (0)20 7418 8900 |
Dr Christopher Golden |
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Oliver Jackson |
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Northland Capital Partners Limited
(BROKER) |
+44
(0)203 861 6625 |
Patrick Claridge/ David Hignell |
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John Howes/ Rob Rees (Broking) |
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Walbrook PR Ltd. (UK FINANCIAL PR & IR) |
+44 (0) 20 7933 8780 / motifbio@walbrookpr.com |
Paul McManus |
Mob:
+44 (0)7980 541 893 |
Mike Wort |
Mob:
+44 (0)7900 608 002 |
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MC
Services AG (EUROPEAN IR) |
+49 (0)89
210 2280 |
Raimund Gabriel |
raimund.gabriel@mc-services.eu |
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The Trout Group (US IR) |
+1 (646
)378-2938 |
Michael Gibralter |
mgibralter@troutgroup.com |
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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: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 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.
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