TIDMMTFB
Motif Bio PLC
19 April 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Announces New Iclaprim Data being Presented at ECCMID
2018
-- Positive efficacy and safety highlights from Phase 3 REVIVE-2 trial in ABSSSI
-- Potential to avoid costs related to vancomycin-associated acute kidney injury in ABSSSI
-- Data continue to support iclaprim activity against MRSA and other drug-resistant pathogens
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announced that new clinical and pre-clinical data with
its investigational drug candidate iclaprim are being presented at
the 28(th) European Congress of Clinical Microbiology and
Infectious Diseases (ECCMID 2018).
Positive efficacy and safety results from REVIVE-2 Phase 3 trial
in ABSSSI
The REVIVE-2 study was a global Phase 3 trial evaluating
iclaprim in patients with acute bacterial skin and skin structure
infections (ABSSSI). As previously reported, the study met its
primary endpoint of non-inferiority (NI) (10% margin) compared to
vancomycin, the current standard of care, at the early time point
(ETP), 48 to 72 hours after the start of administration of the
study drug, in the intent-to-treat (ITT) patient population.
Iclaprim also achieved NI (10% margin) at the test of cure (TOC)
endpoint, 7 to 14 days after study drug discontinuation, in the ITT
patient population.
More detailed safety results are being presented at the
conference. Iclaprim was well tolerated in the trial, and 75% of
adverse events in the study were categorized as mild. Levels of
serum creatinine, a blood test that measures kidney function, were
not affected in patients using iclaprim compared to vancomycin.
There were no study-drug related treatment emergent adverse events
related to nephrotoxicity (kidney toxicity) reported for patients
treated with iclaprim, compared to 2 (0.7%) for vancomycin. There
were no deaths in the iclaprim arm and one in the vancomycin
arm.
Thomas L. Holland, M.D., MSc-GH, Assistant Professor of
Medicine, Duke University School of Medicine, who is presenting the
data, said: "The results from this study show that iclaprim was
efficacious and well tolerated and did not appear to cause kidney
injury. Based on these findings, I believe that iclaprim has the
potential to be a useful addition to the treatment armamentarium
for patients with ABSSSI suspected or confirmed to be due to
Gram-positive pathogens, particularly those at high risk of kidney
injury."
Iclaprim potential to avoid costs related to
vancomycin-associated acute kidney injury (VA-AKI) in patients
hospitalized for ABSSSI
Data are also being presented on potential cost savings
opportunities for hospitals by using iclaprim to treat ABSSSI and
so avoiding costs related to VA-AKI. Patients who are obese,
diabetic or who have renal impairment are at particular risk for
VA-AKI. Vancomycin is the most frequently prescribed antibiotic for
adults hospitalized with ABSSSI.
In a separate study, also conducted by Tom Lodise, Ph.D.,
PharmD, Professor at Albany College of Pharmacy and Health
Sciences, and his colleagues, evaluating the frequency of VA-AKI
and healthcare utilization among Veterans' Affairs patients
hospitalized with skin and skin structure infections, VA-AKI
incidence was 9.2%. Hospital length of stay was extended by five
days for patients with VA-AKI, and many patients with VA-AKI
required a nephrology physician consultation and acute
dialysis.
Recent in vitro data support iclaprim activity against MRSA and
other drug-resistant pathogens
Data are being presented that show that iclaprim continues to be
active against a variety of antibiotic-resistant pathogens like
methicillin-resistant (MRSA) and methicillin-susceptible (MSSA)
Staphylococcus aureus. Iclaprim and the comparator antibiotics were
tested against MRSA, MSSA and other skin and soft tissue pathogens
collected during 2015-2016 from Europe.
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive Officer)
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0) 20 7933 8780
Paul McManus/Helen Cresswell/Lianne
Cawthorne
MC Services AG (EUROPEAN IR) raimund.gabriel@mc-services.eu
Raimund Gabriel +49 (0)89 210 2280
Solebury Trout (US IR) + 1 (646) 378-2936
Meggie Purcell mpurcell@troutgroup.com
Russo Partners (US PR) +1 (858) 717-2310 or +1 (212)
845 4272
David Schull david.schull@russopartnersllc.com
Travis Kruse, Ph.D. travis.kruse@russopartnersllc.com
Note to Editors:
About Iclaprim
Iclaprim is a novel investigational antibiotic that has a
different and underutilised mechanism of action compared to other
antibiotics. Iclaprim exhibits potent in vitro activity against
Gram-positive clinical isolates of many genera of staphylococci,
including methicillin-resistant Staphylococcus aureus (MRSA).
Iclaprim is rapidly bactericidal, achieving 99.9% in vitro kill
against MRSA within 4 to 6 hours of drug exposure versus 8 to 10
hours for vancomycin. To date, iclaprim has been studied in over
1,400 patients and healthy volunteers. In clinical studies iclaprim
has been administered intravenously at a fixed dose with no dosage
adjustment required in patients with renal impairment or in obese
patients. The iclaprim fixed dose may, if approved, help reduce the
resources required in hospitals since dosage adjustment by health
care professionals is avoided and overall hospital treatment costs
may be lower, especially in patients with renal impairment.
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage
biopharmaceutical company engaged in the research and development
of novel antibiotics designed to be effective against serious and
life-threatening infections in hospitalised patients caused by
multi-drug resistant bacteria, including MRSA. The Company's lead
product candidate, iclaprim, is being developed for high-risk MRSA
patient populations. Following positive results from two Phase 3
trials (REVIVE-1 and REVIVE-2), a rolling submission of a New Drug
Application (NDA) with the U.S. Food & Drug Administration
(FDA) for the treatment of acute bacterial skin and skin structure
infections (ABSSSI) has been initiated and is expected to be
completed in the second quarter of 2018. ABSSSI is one of the most
common bacterial infections, with 3.6 million patients hospitalised
annually in the U.S. The Company believes that iclaprim may be
suitable for first-line empiric therapy in ABSSSI patients,
especially those with renal impairment, with or without diabetes.
Unlike many standard of care antibiotics, iclaprim is only
minimally cleared via the kidneys (<2% of the administered dose
was recovered unchanged in the urine). No nephrotoxicity was
observed with iclaprim in the REVIVE Phase 3 trials and dosage
adjustment has not been required in patients with renal
impairment.
Clinical and microbiology data indicate iclaprim has a targeted
Gram-positive spectrum of activity, low propensity for resistance
development, fixed dose administration and favourable tolerability
profile. The Company also 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 was
conducted to study iclaprim in patients with HABP. Iclaprim has
been studied in an animal model of pulmonary MRSA infection which
mimics the pathophysiology observed in patients with cystic
fibrosis. Iclaprim has been granted orphan drug designation by the
U.S. FDA for the treatment of Staphylococcus aureus lung infections
in patients with cystic fibrosis.
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track status.
Upon acceptance by the FDA of a New Drug Application (NDA),
iclaprim will receive Priority Review status and, if approved as a
New Chemical Entity, 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.
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, and (x) 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 10, 2018, 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 company news service from the London Stock Exchange
END
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