TIDMMTFB
RNS Number : 4604N
Motif Bio PLC
09 August 2017
Motif Bio plc
("Motif" or the "Company")
Motif Bio's second Phase 3 clinical trial in ABSSSI finishes
patient treatment phase
Motif Bio plc (AIM/NASDAQ: MTFB), the clinical stage
biopharmaceutical company specialising in developing novel
antibiotics, announced today that the last patient has completed
the treatment phase in REVIVE-2, the second Phase 3 clinical trial
investigating the safety and efficacy of iclaprim in patients with
acute bacterial skin and skin structure infections (ABSSSI).
REVIVE-2 is a 600-patient double-blinded, global, multicentre
trial in patients with ABSSSI that compares the safety and efficacy
of an intravenous 80mg dose of iclaprim with vancomycin also
administered intravenously at a dose of 15mg/kg. Treatments were
administered every 12 hours for 5 to 14 days. REVIVE-2 followed the
same protocol as REVIVE-1, which has completed with positive
topline results announced on 18 April 2017. As in REVIVE-1, the
primary endpoint of REVIVE-2 is non-inferiority (10% margin)
compared to vancomycin at the early time point, 48 to 72 hours
after the start of administration of the study drug, in the
intent-to-treat (ITT) patient population. Non-inferiority (10%
margin) at the test of cure endpoint, 7 to 14 days after study drug
discontinuation, in the ITT patient population will also be
measured. The top-line data from REVIVE-2 are expected during the
fourth quarter of 2017.
Successful results from the two REVIVE trials are expected to
satisfy both US FDA and EMA requirements for regulatory submission
for intravenous iclaprim in the treatment of ABSSSI. Submission of
a New Drug Application (NDA) for iclaprim for the treatment of
ABSSSI is anticipated in the first half of 2018.
Graham Lumsden, CEO of Motif Bio, commented: "The last patient
treated in our REVIVE-2 trial is another key milestone for the
Company that keeps us on track to be able to submit an NDA next
year. We thank the patients and investigators who participated in
REVIVE-2. We believe that iclaprim, if approved, could be an
important option for hospitalised patients with ABSSSI, especially
for those patients who also have kidney disease with or without
diabetes. Unlike current standard of care antibiotics, in clinical
trials to date, nephrotoxicity has not been observed with iclaprim
and dosage adjustment has not been required in renally impaired
patients. It is estimated that up to 26% of the 3.6 million ABSSSI
patients hospitalised annually in the U.S. have kidney
disease."
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief
Executive Officer)
Robert Dickey IV (Chief
Financial Officer)
Peel Hunt LLP (NOMAD
& BROKER) + 44 (0)20 7418 8900
Dr Christopher Golden
Oliver Jackson
Northland Capital Partners
Limited (BROKER) +44 (0)203 861 6625
Patrick Claridge/ David
Hignell
John Howes/ Rob Rees
(Broking)
Walbrook PR Ltd. (FINANCIAL +44 (0) 20 7933 8780 or
PR & IR) motifbio@walbrookpr.com
Paul McManus Mob: +44 (0)7980 541 893
Mike Wort Mob: +44 (0)7900 608 002
MC Services AG (EUROPEAN
IR) +49 (0)89 210 2280
Raimund Gabriel
The Trout Group (US
IR) +1 (646 )378-2938
Michael Gibralter mgibralter@troutgroup.com
Notes to Editors
About Iclaprim
Iclaprim is a novel antibiotic that has a different and
underutilised mechanism of action compared to other antibiotics.
Iclaprim exhibits potent 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 1,300 patients and healthy
volunteers. Iclaprim is 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 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 renally impaired
patients.
About Motif Bio
Motif Bio plc (AIM: 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
(methicillin-resistant Staphylococcus aureus). The Company's lead
product candidate, iclaprim, is being developed for high risk MRSA
patient populations. The first proposed indication, and near-term
commercial opportunity, is for the treatment of acute bacterial
skin and skin structure infections (ABSSSI), one of the most common
bacterial infections, with 3.6 million patients hospitalised
annually in the U. S. The Company believes that iclaprim is
suitable for first-line empiric therapy in ABSSSI patients,
especially those with renal impairment, with or without diabetes,
due to its underutilised mechanism of action, targeted spectrum of
activity, low propensity for resistance development, fixed dose
administration, clearance of inactive metabolites through the
kidneys 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
and iclaprim has demonstrated initial evidence of efficacy in a
Phase 2 trial in patients with HABP. Additionally, in a clinical
study evaluating the tissue distribution of an IV dose of Iclaprim
in relevant lung compartments, high concentrations were found in
epithelial lining fluid and alveolar macrophages, achieving levels
up to 20- and 40-fold higher, respectively, than in plasma.
Iclaprim has been studied in an animal model of chronic pulmonary
MRSA infection which mimics the pathophysiology observed in
patients with cystic fibrosis. Data will be presented at ID Week in
October 2017. Iclaprim has received Qualified Infectious Disease
Product (QIDP) designation from the FDA together with Fast Track
status. Upon acceptance of the 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 data 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 plc's
Annual Report on Form 20-F filed with the SEC on May 1, 2017, which
is available on the SEC's web site, www.sec.gov. Motif Bio plc
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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