TIDMMTFB
RNS Number : 9595P
Motif Bio PLC
14 February 2019
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulation (EU) No. 596/2014. Upon the publication
of this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Receives Complete Response Letter from the FDA
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 motifbio@walbrookpr.com
Cawthorne
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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