Motif Bio Signs Agreement with Lamellar Biomedical
May 01 2019 - 2:00AM
Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that the Company has signed an
agreement with Lamellar Biomedical Limited (Lamellar) under which
Motif Bio will conduct an in vivo pre-clinical study evaluating
iclaprim in combination with Lamellar’s patented LAMELLASOME™
technology. Iclaprim has been granted U.S. orphan drug designation
for Staphylococcus aureus pneumonia in patients with Cystic
Fibrosis (CF). Lamellar’s LAMELLASOME™ candidate LMS-611, which has
mucokinetic (mucus clearing) properties, has demonstrated
antibiotic potentiation (the enhancement of certain properties of
antibiotics) and has European orphan drug designation for CF.
The companies believe that, based on
pre-clinical data with the two individual components, the
combination could be a promising potential treatment for lung
infections in patients with CF.
Dr. Graham Lumsden, Chief Executive
Officer of Motif Bio, said: “We have been looking
for a way to optimise the development of iclaprim in patients with
CF. We are excited about the preliminary data we have seen with
Lamellar’s technology and look forward to evaluating it in
combination with iclaprim.”
Dr. Alex McLean, Chief Executive Officer
of Lamellar Biomedical, said: “CF is a key area of
interest for Lamellar. We are delighted to announce this
partnership with Motif Bio, which will evaluate the antibiotic
potentiation properties of our LAMELLASOME™ technology in
combination with iclaprim. This collaboration augments our own work
in this orphan indication, which is focused on a novel nucleic
acid-based therapeutic, as we strive to develop a range of highly
effective treatment options for patients with CF.”
For further information please contact:
FOR MOTIF BIO: Motif Bio plc |
info@motifbio.com |
Graham
Lumsden (Chief Executive Officer) |
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|
|
Walbrook PR Ltd.
(UK FINANCIAL PR & IR) |
+44 (0) 20
7933 8780 |
Paul McManus/Helen
Cresswell/Lianne 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 |
|
|
FOR LAMELLAR
BIOMEDICAL: |
|
|
|
Lamellar
Biomedical Ltd |
+44 (0)
1698 748 832 |
Dr Alec McLean (CEO) |
+44 (0)
1698 532 163 |
|
|
Citigate Dewe
Rogerson (LAMELLAR FINANCIAL PR) |
|
David Dible/Pip
Batty/Shabnam Bashir |
david.dible@citigatedewerogerson.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.
About Lamellar Biomedical
Lamellar Biomedical Limited (Lamellar) is an
innovative biotechnology company pioneering new approaches for the
transfer of functional nucleic acids. The Company’s unique and
versatile LAMELLASOME™ platform has been designed for the safe and
effective delivery of nucleic acid-based therapeutics and for the
potentiation of antibiotics. Lamellar believes that its LAMELLASOME
technology will play a key role in realising the potential of
mRNAs, siRNAs, miRs, plasmids and other nucleic acids in
development offering the potential to revolutionise the treatment
of many rare and intractable diseases. It also believes that its
technology could be used to improve the utility of antibiotics in a
range of indications including Cystic Fibrosis.
LAMELLASOME™ formulations have been shown to be
effective in delivering functional nucleic acids to a range of cell
types including macrophages, human pulmonary fibroblasts and human
dendritic cells. The technology has also been successfully used for
the in vivo delivery of functional nucleic acids. LAMELLASOME
monotherapy formulations have excellent preclinical safety, a very
high NOAEL (taken from inhalation toxicology) and excellent
clinical safety and tolerability profile.
Lamellar is developing its own pipeline of
nucleic acid-based therapeutics, the most advanced of which target
two areas of unmet clinical need: Idiopathic Pulmonary Fibrosis and
Cystic Fibrosis.
Founded in 2007, Lamellar is backed by both
institutional and private investors, including Invesco, Scottish
Enterprise, Barwell Plc, TRI Capital and has multiple research
collaborations with world renowned institutions and
universities.
Forward-Looking Statements for Motif
Bio
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.
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