TIDMMTFB
RNS Number : 3497B
Motif Bio PLC
06 June 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 Announces Path Forward for Iclaprim following Receipt
of FDA Meeting Minutes
Conference call scheduled for Thursday, June 6, 2019 at 8:00 AM
EDT/1:00 PM BST/2:00 PM CET
Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that the Company has received the
official minutes of the Type A meeting the Company held with the
U.S. Food & Drug Administration (FDA or Agency) on May 3, 2019,
to discuss the points raised in the Complete Response Letter (CRL)
related to the New Drug Application (NDA) for iclaprim, for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI). The minutes indicate that an additional clinical trial
will be required prior to granting marketing approval to address
the Agency's continued concerns about potential liver toxicity. The
Company has been encouraged by the FDA to put forth a proposal for
a future study and to submit it for review. The Company plans to
request a meeting with the Agency to discuss the design of the
study, including the appropriate patient population to be
evaluated.
Dr. Graham Lumsden, Chief Executive Officer, said: "We now have
confirmation of what will be required for a path forward for
iclaprim. We intend to meet with the Agency to agree on the
specific requirements of the trial, which will enable us to
estimate its size and scope and, therefore, the costs and funding
requirements. In parallel, we expect to continue our discussions
with potential commercial partners and will determine the best
options for funding the trial once we have clarity from the
FDA."
"We continue to believe that iclaprim has the potential to be an
important new treatment option for hospitalised patients with
ABSSSI and potentially also in patients with hospital-acquired
bacterial pneumonia, including ventilator-associated bacterial
pneumonia. In addition, we are exploring the use of iclaprim in
other disease areas, including orphan indications such as
Staphylococcus aureus lung infections in patients with cystic
fibrosis and in ophthalmology, as evidenced by recently announced
collaborative agreements. Completing the steps necessary to provide
the additional trial data to respond to the Complete Response
Letter is our top priority. We are also continuing our business
development activities to position Motif Bio for long-term growth
by building a robust development pipeline. In parallel with our
focus on iclaprim, we continue to pursue a variety of attractive
opportunities in the anti-infectives space, as well as in other key
therapeutic areas."
As of May 31, 2019, the Company had a cash balance of $2.3
million and $7.1 million of outstanding debt drawn from the
Hercules Loan Facility. The Company believes the current cash
position can support continued operations into September 2019 with
diligent cash management. The Company will need to raise additional
capital, which may be through equity financing and/or from
non-dilutive sources. The Company is evaluating options to
determine the funding strategy that will be most favourable for
shareholders and will provide an update to the market in due
course.
Conference call scheduled
Motif Bio will hold a conference call on Thursday, June 6, 2019
at 8:00 AM EDT/1:00 PM BST/2:00 PM CET.
You may pre-register for the call here
http://dpregister.com/10131464. Callers who pre-register will be
given a conference passcode and unique PIN to gain immediate access
to the call and bypass the live operator. Participants may
pre-register at any time, including up to and after the call start
time.
If you have not pre-registered, please dial in at least 10
minutes in advance of the call and refer to the Motif Bio call.
The dial-in details are as follows:
United Kingdom: +44 (0)20 3514 3188
Germany: +49 (0)69-22221534
United States: +1 412-317-5413
The call will also be webcast. Please visit the Investors -
Events and Presentations section of Motif Bio's website at
http://ir.motifbio.com/phoenix.zhtml?c=254416&p=irol-calendar
for a link to the webcast.
The person who arranged for the release of this announcement on
behalf of Motif Bio plc was Graham Lumsden, Chief Executive
Officer.
For further information please contact:
Motif Bio plc ir@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Peel Hunt LLP (NOMAD & JOINT BROKER) + 44 (0)20 7418 8900
Dr Christopher Golden
Oliver Jackson
SP ANGEL CORPORATE FINANCE LLP (JOINT
BROKER) +44 (0)20 3470 0470
David Hignell/ Vadim Alexandre /Rob
Rees
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0)20 7933 8780
Paul McManus/Lianne Cawthorne motifbio@walbrookpr.com
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
LifeSci Advisors (U.S. IR) +1 (646) 597 6989
Bob Yedid bob@lifesciadvisors.com
Russo Partners (U.S. PR) +1 (858) 717 2310 or +1 (212) 845
4272
David Schull david.schull@russopartnersllc.com
Note to Editors:
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 pre-clinical development for this
indication.
Iclaprim 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 15, 2019, 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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