Motif Bio PLC NIH to Evaluate Iclaprim Activity against Listeria
19 Agosto 2019 - 8:00AM
RNS Non-Regulatory
TIDMMTFB
Motif Bio PLC
19 August 2019
Motif Bio plc
("Motif Bio" or the "Company")
NIH to Evaluate Iclaprim Activity against Listeria
Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that the Company will be utilising
NIAID's(1) suite of preclinical services through JMI Laboratories
to evaluate iclaprim against Listeria monocytogenes, a
Gram-positive bacteria causing food-borne, life-threatening
infections. The study, to be funded by NIAID, follows earlier in
vitro testing in which iclaprim was >=32-fold more potent than
standard-of-care ampicillin and demonstrated consistent
extracellular as well as intracellular activity against L.
monocytogenes(2) .
Listeriosis is a rare but serious infection usually caused by
eating food, such as cheese and other dairy products, deli meat and
produce that has been contaminated with L. monocytogenes. An
estimated 1,600 people in the U.S. get listeriosis each year, and
the infection is most likely to sicken pregnant women and their
newborns, adults aged 65 or older, and people with weakened immune
systems. The disease can lead to septicaemia or meningitis, and
about 260 people in the U.S. die from listeriosis annually. If
treatment is required, patients are generally given IV antibiotics
- ampicillin alone or in conjunction with another antibiotic.
David Huang, M.D., Ph.D., Chief Medical Officer of Motif Bio,
said: "Listeriosis is a potentially life-threatening infection for
which more effective treatment options are needed. If the results
of this study confirm that iclaprim has potent activity against L.
monocytogenes, we believe that iclaprim could be a potentially
useful treatment option and would warrant further study."
(1) NIAID: National Institute of Allergy and Infectious
Diseases.
(2) Huang, D. Letter to the Editor: Extracellular and
intracellular activity of iclaprim against Listeria monocytogenes.
International Journal of Antimicrobial Agents, 53 (2019)
106-107.
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 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
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. In February 2019, the Company received a Complete
Response Letter (CRL) related to the New Drug Application (NDA) for
iclaprim for the treatment of ABSSSI. Additional information
regarding the CRL can be found in Motif Bio's Annual Report on Form
20-F filed with the SEC on April 15, 2019. Minutes from a meeting
with the FDA to discuss the points raised in the CRL were received
in June 2019 and indicated 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 was encouraged by the FDA to put forth a proposal for a
future study and submitted such a proposal for review in July 2019.
Motif Bio has been granted a meeting, scheduled for September 19,
2019, with the Agency to discuss the proposed patient population
and study design.
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. Additionally, there can be no assurance that
Motif Bio will regain compliance with Nasdaq rules or maintain its
ADS listing on Nasdaq. Motif Bio undertakes no obligation to update
or revise any forward-looking statements.
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