Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announced today that new iclaprim data are being
presented at the 28th European Congress of Clinical Microbiology
and Infectious Diseases (ECCMID 2019) in Amsterdam, The
Netherlands.
Efficacy analysis by lesion size
demonstrates iclaprim had comparable efficacy to vancomycin across
broad range of lesion sizes in REVIVE Phase III study
patients
Larger-size acute bacterial skin and skin
structure infection (ABSSSI) lesions may be more difficult to
treat. A post-hoc analysis by lesion size of the pooled data from
the REVIVE-1 and REVIVE-2 Phase III trials evaluating iclaprim
versus vancomycin for the treatment of ABSSSI patients showed that
fixed dosing of iclaprim had similar efficacy results compared to
weight/renal function-based dosing of vancomycin across a broad
range of lesion sizes, including lesions 800 cm2 or greater.
Clearance of bacteremia comparable in
patients treated with iclaprim versus vancomycin in pooled analysis
of REVIVE Phase III study results
Secondary bacteremia is a complication among
patients with ABSSSI and is associated with increased morbidity and
mortality. A post-hoc analysis evaluated bacteremia outcomes in
patients in the REVIVE trials. There were 12/592 patients in the
iclaprim arm and 12/606 patients in the vancomycin arm with
secondary bacteremia. In each group, 83% of patients cleared their
bacteremia by the test of cure visit (7 to 14 days after end of
therapy).
Pharmacokinetics of iclaprim support use
of fixed dosing regimen in ABSSSI patients
A pharmacokinetic analysis of iclaprim-treated
patients in the REVIVE Phase III trials evaluated iclaprim
clearance and concentration. Age had a small effect on clearance
and with it on AUCi. Clearance decreased by about 10% for each
decade over 50 years. Clearance was not affected by weight, gender,
renal function, hepatic function or race. There were modest
increases related to drug concentration (as measured by AUC and
Cmaxii) in patients 65 years and older compared to younger
patients, likely due to slower clearance. These differences were
not considered clinically meaningful. The results support that no
iclaprim dose adjustments are required for elderly patients, nor
for obese or renally impaired patients, in this patient
population.
Recent in vitro data support iclaprim
activity against Gram-positive bacteria collected from patients
with skin and skin structure infections
Data are being presented that show that iclaprim
continues to be active against a variety of antibiotic-resistant
pathogens like methicillin-resistant (MRSA),
methicillin–susceptible (MSSA) Staphylococcus aureus, and other
Gram-positive skin and soft structure pathogens collected during
2017 from Europe and the U.S.
“It is important to see that these subgroup
analyses in the REVIVE Phase III trials show that results with
iclaprim were comparable to vancomycin, even in patients with more
challenging-to-treat skin infections, such as those with large
lesions or with bacteremia,” said Thomas L. Holland, M.D.,
MSc-GH, Assistant Professor of Medicine, Duke University School of
Medicine. “We continue to need new options to treat
patients with ABSSSI, particularly those at risk of
vancomycin-associated kidney injury.”
Real-world incidence of
vancomycin-associated nephrotoxicity in hospitalised patients with
ABSSSI shown to be >3-fold higher than in
recent trials
Michael J. Rybak, Pharm.D., MPH, Ph.D.,
Professor of Pharmacy and Medicine, Director, Anti-Infective
Research Laboratory, Eugene Applebaum College of Pharmacy and
Health Sciences, Wayne State University, Detroit, Michigan, USA led
a retrospective, cohort study at two medical centers in Detroit
from February to June 2018. A total of 82 hospitalised adults
treated with vancomycin (≥72 hours) for ABSSSI and with ≥1 baseline
acute kidney injury (AKI) risk factors were evaluated. Patients
with severe renal impairment or AKI prior to vancomycin treatment
were excluded. The study found that the incidence of nephrotoxicity
in patients with ≥1 AKI risk factor was >3-fold higher than in
recent trials, underscoring the importance of close monitoring
and/or selection of an alternative agent in at-risk ABSSSI
patients.
For further information please contact:
Motif Bio plc |
ir@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 |
motifbio@walbrookpr.com |
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MC
Services AG (EUROPEAN IR) |
+49 (0) 89
210 2280 |
Raimund
Gabriel |
raimund.gabriel@mc-services.eu |
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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 BioMotif 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 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.
i AUC – Area under the curve: Mathematical method for measuring
drug concentrations.
ii Cmax – Maximum concentration: The peak concentration that a
drug achieves in the body after the drug has been
administered and before administration of a second dose.
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