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Motif Bio PLC
21 December 2017
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio REVIVE-1 Phase 3 Study Results with Iclaprim Published
in Peer-reviewed Journal, Clinical Infectious Diseases
-- Iclaprim met the primary endpoint
-- Iclaprim was well tolerated in the study
-- Additional data from the previously announced topline results
are included in the publication
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that the results from REVIVE-1, a
global Phase 3 clinical trial evaluating the investigational drug
candidate iclaprim in patients with acute bacterial skin and skin
structure infections (ABSSSI) have been published in the
peer-reviewed journal, Clinical Infectious Diseases. The positive
topline results from this study were announced in April 2017.
In the intent-to-treat (ITT) patient population, 80.9% of
patients treated with iclaprim and 81% of patients treated with
vancomycin achieved the primary endpoint of early clinical response
(ECR), defined as a greater than or equal to 20% reduction in
lesion size compared with baseline, at the early time point (ETP),
48 to 72 hours after the start of administration of the study drug.
Non-inferiority (NI) (10% margin) thus was confirmed for iclaprim
compared to vancomycin. Secondary analyses in the study included
response to treatment at end of therapy (EOT), at test of cure
(TOC), 7-14 days after the last dose of study drug, and safety and
tolerability.
The ITT study population included 598 randomized patients from
clinical trial sites in the U.S., Europe and Latin America.
Patients were randomized 1:1 to receive either iclaprim 80mg IV or
vancomycin 15 mg/kg IV. Treatments were administered every 12 hours
for 5 to 14 days. Baseline and demographic characteristics were
comparable between the two groups.
80% (16/20) of diabetic patients in the iclaprim group and 74%
(26/35) of diabetic patients treated with vancomycin achieved ECR
at ETP. 83% (5/6) of iclaprim-treated patients with moderate/severe
renal impairment and 75% (9/12) of vancomycin-treated patients with
moderate/severe renal impairment achieved ECR at ETP.
Iclaprim was well tolerated in the study. Treatment emergent
adverse events (TEAEs) were generally mild, including headache
(10.2% and 2.4%), nausea (9.9% and 5.7%), and fatigue (6.1% and
3.0%), reported in patients in the iclaprim group compared to the
vancomycin group, respectively. TEAEs leading to discontinuation
were 2.7% and 4.4% in patients in the iclaprim and vancomycin
group, respectively. There were no study-drug related TEAEs related
to nephrotoxicity in patients treated with iclaprim compared to
three reported cases of acute kidney injury in patients treated
with vancomycin.
No significant differences were seen between treatment groups in
mean values or mean changes in other routine serum laboratory
parameters, urinalysis results, vital signs or physical
examinations during treatment.
William O'Riordan, MD, FACEP, Chief Medical Officer, eStudySite
and principal investigator of the REVIVE-1 study, said: "ABSSSI is
a serious infection for which patients are frequently hospitalised
for several days. Many of these patients have co-morbidities, such
as renal impairment and diabetes. For these patients in particular,
there is an urgent need for safer, more effective treatment
options. Iclaprim demonstrated strong efficacy and safety results,
including no kidney toxicity, in REVIVE-1, the first of two
positive Phase 3 trials in ABSSSI. With this profile and its fixed
dosing, iclaprim, if approved, could be an important new treatment
option for these very sick patients."
Iclaprim has been designated as a Qualified Infectious Disease
Product (QIDP) by the U.S. Food and Drug Administration (FDA). This
designation includes Priority Review upon acceptance of a New Drug
Application (NDA), and, if approved, it is anticipated that
iclaprim will be eligible to receive 10 years of market exclusivity
in the U.S. from the date of approval. The FDA has also granted
Fast Track designation for iclaprim. Motif Bio plans to submit an
NDA by the end of the first quarter of 2018.
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief
Executive Officer)
Walbrook PR Ltd. (UK +44 (0) 20 7933 8780 /
FINANCIAL 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 raimund.gabriel@mc-services.eu
The Trout Group (US
IR) +1 (646 )378-2963
Meggie Purcell mpurcell@troutgroup.com
Lazar Partners (US PR) motiflp@lazarpartners.com
Chantal Beaudry +1 (646) 871-8480
Amy Wheeler +1 (646) 871-8486
Notes to Editors
About Acute Bacterial Skin and Skin Structure Infections
Acute bacterial skin and skin structure infections (ABSSSI) are
one of the most common bacterial infections. ABSSSI are potentially
serious infections that may require hospitalisation, intravenous
antibiotics and/or surgical intervention and 3.6 million patients
are hospitalised annually in the U.S. for ABSSSI. An ABSSSI is
defined as a bacterial infection of the skin with a lesion size
area of at least 75 cm(2) and includes cellulitis/erysipelas, wound
infections, and major cutanenous abscesses. Approximately 85% of
ABSSSI are caused by Gram-positive bacteria, usually Staphylococcus
aureus, including methicillin-resistant S. aureus (MRSA) and
Streptococcus pyogenes.
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
1,300 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. The first proposed indication, and near-term
commercial opportunity, is for the treatment of ABSSSI, 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 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 patients with renal
impairment.
Iclaprim has an underutilised mechanism of action compared to
other antibiotics. 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. Additionally, data support that
the inactive metabolites of iclaprim clear through the kidneys. 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 US 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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