TIDMMTFB
RNS Number : 6224S
Motif Bio PLC
04 October 2017
The information contained within this announcement is deemed by
Motif Bio plc to constitute inside information as stipulated under
the Market Abuse Regulation (EU) No. 596/2014. Upon the publication
of this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Announces Positive Topline Results for iclaprim in the
REVIVE-2 Phase 3 Study
-- Iclaprim met the primary endpoint
-- Iclaprim was well tolerated in the study
-- NDA submission expected in the first quarter of 2018
Company to host a conference call today at 2.00 pm CET/1.00 pm
BST/8:00 am EDT
Motif Bio plc (AIM/NASDAQ: MTFB), the clinical stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced positive topline results from
REVIVE-2, a global Phase 3 clinical trial evaluating the
investigational drug candidate iclaprim in patients with acute
bacterial skin and skin structure infections (ABSSSI).
Iclaprim achieved the 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.
Timepoint Endpoint Iclaprim Vancomycin % Difference
N=295 N=305 (95% CI)
Early Clinical
ETP Response (ECR)* 231 (78.3%) 234 (76.7%) 1.58
(primary endpoint) (-5.10, 8.26)
------------ ------------ ---------------
TOC Clinical cure 230 (78.0%) 237 (77.7%) 0.26
(-6.39, 6.91)
---------------------------------------- ------------ ------------ ---------------
*>20% reduction of lesion area at 48-72 hours
In an analysis of a pre-specified secondary endpoint, 54.6% of
patients receiving iclaprim demonstrated resolution or near
resolution at end of therapy (EOT), compared to 55.4% of patients
receiving vancomycin (treatment difference: -0.83%, 95% CI: -8.80%
to 7.13%). In another pre-specified secondary endpoint analysis,
using a modified clinical cure TOC endpoint defined by a >90%
reduction in lesion size at TOC, no increase in lesion size since
ETP and no requirement for additional antibiotics, clinical cure
was seen in 71.9% of patients receiving iclaprim and 70.5% of
patients receiving vancomycin (treatment difference: 1.37%, 95% CI:
-5.88% to 8.62%).
Graham Lumsden, Chief Executive Officer of Motif Bio commented:
"With the positive results announced today from REVIVE-2, we have
now successfully completed the two required Phase 3 trials in
ABSSSI and plan to submit an NDA to the U.S. FDA by the end of the
first quarter of 2018. This is a testament to the incredible
efforts of our team at Motif who have worked tirelessly to get us
to this stage. We believe that these results validate our belief in
iclaprim as a potential new antibiotic candidate for patients with
serious and life-threatening infections. I thank the patients and
clinicians who participated in this important study.
"We believe that iclaprim, if approved, could be an important
option for patients with ABSSSI, especially for those patients who
may also have kidney disease, with or without diabetes. It is
estimated that up to 26% of the 3.6 million ABSSSI patients
hospitalised annually in the U.S. have kidney disease. Unlike
current standard of care antibiotics, in clinical trials to date,
kidney toxicity has not been observed with iclaprim and dosage
adjustment has not been required in patients with renal impairment.
Iclaprim may be an important option for the growing population of
patients with ABSSSI and kidney disease who need a safe and
effective antibiotic targeting Gram-positive bacteria, including
MRSA."
G. Ralph Corey, MD, Vice Chair for Education and Global Health,
School of Medicine Gary Hock Professor, Global Health Director,
Hubert-Yeargan Center for Global Health, Duke University School of
Medicine and principal investigator of the REVIVE-2 study, said:
"ABSSSI is a serious infection for which patients are frequently
hospitalized 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 better
treatment options. With the strong efficacy and safety results from
REVIVE-2, including no renal toxicity, as well as fixed dosing,
iclaprim, if approved, could be an important new treatment option
for these patients."
REVIVE-2 Overview and Adverse Event (AE) Summary
REVIVE-2 was a 600-patient double-blinded, active-controlled,
global trial in patients with ABSSSI that compared the safety and
efficacy of an 80mg intravenous dose of iclaprim with a 15mg/kg
intravenous dose of vancomycin. Treatments were administered every
12 hours for 5 to 14 days. The trial involved over 40 clinical
centres in the U.S., South America and Europe.
Iclaprim was well tolerated in the study, with most adverse
events categorized as mild.
Iclaprim Vancomycin
N=299 N=302
TEAEs (Treatment Emergent
Adverse Events) 140 (46.8%) 133 (44.0%)
------------ ------------
Study drug related TEAEs 42 (14.0%) 39 (12.9%)
------------ ------------
TEAEs leading to discontinuation
of study drug 16 (5.4%) 17 (5.6%)
------------ ------------
TEAE-related SAEs (Serious
AEs) 14 (4.7%) 12 (4.0%)
------------ ------------
Deaths 0 1
------------ ------------
Motif Bio plans to present more detailed data from this study at
an upcoming scientific forum.
Iclaprim has been designated as a Qualified Infectious Disease
Product (QIDP) by the U.S. Food and Drug Administration (FDA) for
the treatment of ABSSSI and hospital acquired bacterial pneumonia
(HABP), which enables Priority Review following submission of an
NDA. 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.
Conference call details
Motif Bio management will host a conference call regarding this
announcement at 8:00 am EDT/1.00 pm BST/2.00 pm CET on 4 October
2017. The call may be accessed as follows:
UK: +44 08000288438 (toll free) or +44 02031070289
US: 1 -866-219-5264 (toll free) or 1-703-736-7410
Germany: +49 08001815287 (toll free) or +49 06922224710
Conference passcode: 95686039
A live webcast of the call will be available in the Investors
section of the company's website at www.motifbio.com, and will be
archived there for 30 days.
The person responsible for the release of this announcement on
behalf of Motif Bio plc is Robert Dickey IV, Chief Financial
Officer.
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. (UK FINANCIAL PR & +44 (0) 20 7933 8780 /
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 )378-2938
Michael Gibralter mgibralter@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 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 acute bacterial
skin and skin structure infections (ABSSSI), one of the most common
bacterial infections, with 3.6 million patients hospitalised
annually in the US. 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 chronic pulmonary MRSA infection which mimics
the pathophysiology observed in patients with cystic fibrosis.
Results from this study will be presented at IDWeek 2017(TM) on
October 6, 2017 in San Diego, CA. 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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