TIDMMTFB
Motif Bio PLC
16 April 2019
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Presents New Iclaprim Data at ECCMID 2019
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 28(th) 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 cm(2) 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
AUC[i]. 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 Cmax[ii]) 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)
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0)20 7933 8780
Paul McManus/Helen Cresswell/Lianne motifbio@walbrookpr.com
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
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 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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END
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