Motif Bio Receives Complete Response Letter from the FDA
February 14 2019 - 2:00AM
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announced today that the Company has received a
Complete Response Letter (CRL) from the U.S. Food & Drug
Administration (FDA) regarding the New Drug Application (NDA) for
iclaprim for the treatment of acute bacterial skin and skin
structure infections (ABSSSI). The CRL states that the FDA cannot
approve the NDA in its present form and indicates that additional
data are needed to further evaluate the risk for liver toxicity
before the NDA may be approved. Motif Bio plans to request a
meeting with the FDA as soon as possible to discuss potential
options to address the deficiencies.
Graham Lumsden, Chief Executive Officer
of Motif Bio, said: “We are disappointed for
patients and providers seeking an alternative antibiotic to treat
ABSSSI. We intend to request a meeting with the FDA, which
typically should occur within approximately 30-45 days, to discuss
the CRL. We look forward to working with the Agency to discuss
options to advance iclaprim towards approval.”
At 31 December 2018, the Company had cash of
$12.3 million and $15 million of debt drawn from its Hercules loan
facility. The Company is financed into the second quarter of
2019 but will need to raise capital in the near term.
If approved for the ABSSSI indication as a New
Chemical Entity, iclaprim 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
addition, Motif is building a patent estate to provide additional
protection for iclaprim and has two U.S. method of use
patents issued that will expire in 2037.
The person who arranged for the release of this
announcement on behalf of Motif Bio plc was Jon Gold, Interim Chief
Financial Officer.
For further information please contact:
Motif Bio plc |
ir@motifbio.com |
Graham
Lumsden (Chief Executive Officer) |
|
|
|
Peel Hunt LLP (NOMAD & BROKER) |
+ 44 (0)20 7418 8900 |
Dr
Christopher Golden |
|
Oliver
Jackson |
|
|
|
Walbrook PR Ltd. (UK FINANCIAL PR & IR) |
+44
(0)20 7933 8780 |
Paul
McManus/Helen Cresswell/Lianne Cawthorne |
motifbio@walbrookpr.com |
|
|
MC Services AG (EUROPEAN IR) |
+49 (0)
89 210 2280 |
Raimund
Gabriel |
raimund.gabriel@mc-services.eu |
|
|
Russo Partners (U.S. PR) |
+1
(858) 717-2310 or +1 (212) 845 4272 |
David
Schull |
david.schull@russopartnersllc.com |
Travis
Kruse, Ph.D. |
travis.kruse@russopartnersllc.com |
|
|
Note to Editors:
About Iclaprim
Iclaprim is a novel investigational
antibiotic with a targeted Gram-positive spectrum of activity. In
contrast to commonly used broad-spectrum antibiotics, this
“precision medicine approach” is consistent with antibiotic
stewardship principles which, among other things, seek to reduce
the inappropriate use of broad-spectrum products to avoid the
build-up of resistance and to lessen the impact on the microbiome
of the patient.
Iclaprim has a different and underutilised
mechanism of action compared to most other antibiotics. To date,
iclaprim has been studied in nearly 1,500 patients and healthy
volunteers. Clinical and microbiological data indicate that
iclaprim has a targeted Gram-positive spectrum of activity, low
propensity for resistance development and favourable tolerability
profile. In the REVIVE Phase 3 clinical studies in patients with
acute bacterial skin and skin structure infections (ABSSSI),
iclaprim was 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. Many standard of care Gram-positive antibiotics are not
suitable for hospitalised ABSSSI patients with renal impairment due
to efficacy and/or safety issues.
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) is a
clinical-stage biopharmaceutical company focused on developing
novel antibiotics designed to be effective against serious and
life-threatening infections caused by multi-drug resistant
Gram-positive bacteria, including MRSA. The Company’s lead product
candidate is iclaprim. Motif Bio is seeking approval of iclaprim
from the U.S. Food & Drug Administration (FDA) for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI). More than 3.6 million patients with ABSSSI are
hospitalised annually in the U.S. It is estimated that up to 26% of
hospitalized ABSSSI patients have renal impairment.
The Company also has 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 in patients with HABP has been successfully completed and a
Phase 3 trial is being planned. Additionally, iclaprim has been
granted orphan drug designation by the FDA for the treatment of
Staphylococcus aureus lung infections in patients with cystic
fibrosis and is in preclinical development for this indication.
Iclaprim has received Qualified Infectious
Disease Product (QIDP) designation from the FDA together with Fast
Track status for the ABSSSI indication. If approved for the ABSSSI
indication as a New Chemical Entity, iclaprim 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 market exclusivity is
anticipated. Motif is also building a patent estate to
provide additional protection for iclaprim and has two U.S. method
of use patents issued that will expire in 2037.
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, (x) Motif Bio’s ability to raise additional
capital to sustain its operations and pursue its strategy and (xi)
the factors discussed in the section entitled “Risk Factors” in
Motif Bio’s Annual Report on Form 20-F filed with the SEC on April
10, 2018, which is available on the SEC’s web site, www.sec.gov.
Motif Bio undertakes no obligation to update or revise any
forward-looking statements.
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