TIDMMTFB
RNS Number : 8795Z
Motif Bio PLC
22 May 2019
Motif Bio plc
("Motif Bio" or the "Company")
AGM Statement
Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announces that at the Company's AGM held earlier today
the Company provided the following review of key aspects of its
business and growth strategy.
Iclaprim for treating ABSSSI (acute bacterial skin and skin
structure infections)
-- Type A meeting held with the U.S. FDA on 3(rd) May to discuss the path forward
-- Additional data likely will be required to address the
Agency's concern about a risk of liver toxicity, the size and scope
of which will determine the specific next steps
-- Motif Bio to provide an update once the minutes of the meeting are received
-- Intention remains to partner Iclaprim upon marketing approval
for commercialisation in the U.S. and other global markets
-- Strengthen IP portfolio and partnering position in ex-U.S.
markets by filing method-of-use patents covering fixed dose of
Iclaprim
Near-term expansion opportunities for Iclaprim
-- Cystic fibrosis (Agreement with Lamellar Biomedical Limited)
- To conduct in vivo preclinical studies evaluating Iclaprim in combination with LBL's LMS-611
- Complementary mechanisms of action: LMS-611 breaks down mucus
in the lungs of CF patients, enabling greater penetration and
enhanced activity of antibiotics; Iclaprim accumulates in the lung
alveolar macrophages and has activity against CF-relevant bacteria,
including Staphylococcus aureus
- Iclaprim was granted U.S. orphan drug designation for S.
aureus pneumonia in patients with CF and LMS-611 has European
orphan drug designation for CF
- Lamellar also has a disease-modifying gene therapy product candidate
-- Toxoplasma chorioretinits (Agreement with Otto-von-Guericke University, Magdeburg)
- To evaluate Iclaprim in an in vitro model for ocular
toxoplasmosis, a parasitic disease that may result in severe
life-threatening infections and/or blindness
- Iclaprim has shown promising activity against toxoplasma in vitro
- Study is planned to focus on toxoplasma chorioretinitis, a
progressive and recurring necrotizing retinitis
- To be led by Prof. Dr. Ildiko Rita Dunay, a toxoplasmosis
expert and Director of the Institute of Inflammation and
Neurodegeneration at Otto-von-Guericke University
Additional business development initiatives
-- A concerted business development effort has been ongoing
-- Proactively sought and will continue to seek to license or
acquire assets that could enhance and/or broaden the Company's
development pipeline
-- Continue to be approached and presented with opportunities
based on Motif Bio's demonstrated ability to execute successful
late-stage clinical studies
-- Currently evaluating a number of licensing and partnering opportunities
-- Look forward to discussing additional pipeline developments at the appropriate time
Additional updates
-- Sufficiently funded to reach a decision point regarding
Iclaprim based on the outcome of interactions with the FDA
- As in the past, Motif Bio will continue to evaluate options to
determine the funding strategy that is most favorable for
shareholders and provides flexibility to execute on our clinical
and business development activities
-- Enhanced Board of Directors with the appointment of Andrew
Powell, J.D. as Non-executive Director
- Extensive experience in the life sciences industry and strong
expertise in commercialization strategy, corporate expansion,
governance and M&A
-- Continued to establish Motif Bio within the anti-infectives industry
- April 2019: Presented new Iclaprim data at ECCMID 2019
- Announced yesterday three poster presentations at upcoming ASM Microbe 2019
Summarising Dr. Graham Lumsden, Chief Executive Officer of Motif
Bio, said: "We are very confident in our lead compound Iclaprim's
broad potential as a differentiated and targeted anti-infective
agent, based on the strong clinical safety and efficacy data we
have generated and the important unmet medical and health-economic
needs we believe Iclaprim may fulfill within the hospital-based
antibiotic landscape and other indications. In addition to pursuing
our first potential approval and commercial partnership for
Iclaprim, we are committed to maximizing opportunities to further
expand the value of this asset. We recently announced two
collaborative agreements to evaluate Iclaprim's ability to address
high-need orphan diseases within lung disease and
ophthalmology.
"In parallel, we're continuing our broader business development
efforts to in-license or acquire additional assets. Multiple
opportunities are currently under evaluation based on our proactive
efforts as well opportunities that have been presented to us based
on our demonstrated ability to execute successful late-stage
clinical studies. Our goal is to position Motif Bio for long-term
growth by building a robust development pipeline, both within the
anti-infectives space and potentially other high-growth areas that
we believe have significant therapeutic and commercial potential.
Based on our current pipeline and future opportunities, we believe
there are several exciting pathways for continued value
creation."
No new material information was disclosed during the
meeting.
The AGM was adjourned until 1 PM BST on Friday 31 May 2019 at
the offices of DLA Piper UK LLP at 160 Aldersgate Street London
EC1A 4HT, United Kingdom. The decision to adjourn the AGM follows
consultation with certain of the Company's shareholders relating to
their ability to attend the meeting and the Company has adjourned
the meeting in order to facilitate their participation at the
adjourned AGM.
For further information please contact:
Motif Bio plc ir@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0)20 7933 8780
Paul McManus/Lianne Cawthorne/Helen motifbio@walbrookpr.com
Cresswell
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
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
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END
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