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Motif Bio PLC
11 June 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Announces New Iclaprim Data Presented at ASM Microbe
2018
-- Pooled efficacy and safety data from REVIVE Phase 3 trials presented
-- Data also published in peer-reviewed journal, International Journal of Antimicrobial Agents
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announced that the pooled efficacy and safety data
from its two Phase 3 trials (REVIVE-1 and REVIVE-2) in patients
with acute bacterial skin and skin structure infections (ABSSSI)
treated with its investigational drug candidate iclaprim were
presented at the American Society of Microbiology (ASM) Microbe
2018 meeting in Atlanta, GA (An Analysis of Pooled Efficacy Data
from Two Phase 3 Trials of Iclaprim Compared to Vancomycin for the
Treatment of Acute Bacterial Skin and Skin Structure Infections,
#640 and A Pooled Analysis of Two Phase 3, Randomized,
Double-Blind, Multicenter Studies to Evaluate the Safety of
Intravenous Iclaprim versus Vancomycin, #641). The pooled data
demonstrate that iclaprim was non-inferior to standard-of-care
vancomycin and was well tolerated in this patient population. The
posters are available on the Motif Bio website here. The pooled
data have also been published in the peer-reviewed scientific
journal, International Journal of Antimicrobial Agents
(https://doi.org/10.1016/j.ijantimicag.2018.05.012).
"ABSSSI is a serious infection for which patients may be
hospitalised for several days. Many of these ABSSSI patients have
comorbidities, such as renal impairment and diabetes," said G.
Ralph Corey, MD, Vice Chair for Education and Global Health and
Gary Hock Professor at Duke University School of Medicine and a
principal investigator in the REVIVE-2 trial. "For these patients
in particular, there is an urgent need for better treatment
options. Iclaprim has a fixed dose, with no dosage adjustment
required in patients with renal impairment or in obese patients,
and no kidney toxicity was observed in the REVIVE trials. Iclaprim,
if approved, may offer advantages over standard of care antibiotics
in hospitalised ABSSSI patients, particularly those with renal
impairment and/or diabetes."
Both the REVIVE-1 and REVIVE-2 studies were global Phase 3
trials evaluating iclaprim in patients with ABSSSI. As previously
reported, both studies met their primary endpoints of
non-inferiority (NI) (10% margin) compared to vancomycin, the
current standard of care, at the early timepoint (ETP), 48 to 72
hours after the start of administration of the study drug, in the
intent-to-treat (ITT) patient population. The pooled data set
included over 1,190 patients.
Iclaprim was well tolerated in the two Phase 3 studies compared
to vancomycin. In most patients, adverse events were mild to
moderate, with severe adverse events reported in less than 5% of
all patients in the pooled data set. The most frequent adverse
reactions in both iclaprim and vancomycin-treated patients were
headache and nausea. No deaths occurred among patients treated with
iclaprim, while three deaths occurred in the vancomycin group.
Acute kidney injury or elevated serum creatinine was reported in
seven patients treated with vancomycin, which is known to be
nephrotoxic. In contrast, none of the patients treated with
iclaprim experienced acute kidney injury or elevated serum
creatinine.
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) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
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 with a targeted
Gram-positive spectrum of activity. In contrast to commonly used
broad-spectrum antibiotics, this "precision medicine approach" is
consistent with antibiotic stewardship principles which, among
other things, seek to reduce the inappropriate use of
broad-spectrum products to avoid the build-up of resistance and to
lessen the impact on the microbiome of the patient.
Iclaprim has a different and underutilised mechanism of action
compared to most other antibiotics. 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. To date,
iclaprim has been studied in over 1,400 patients and healthy
volunteers. Clinical and microbiological data indicate that
iclaprim has a targeted Gram-positive spectrum of activity, low
propensity for resistance development and favourable tolerability
profile. 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. Many standard of care
Gram-positive antibiotics are not suitable for hospitalized ABSSSI
patients with renal impairment due to efficacy and/or safety
issues.
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage
biopharmaceutical company focused on developing novel antibiotics
for hospitalised patients and designed to be effective against
serious and life-threatening infections caused by multi-drug
resistant bacteria, including MRSA. The Company's lead product
candidate is iclaprim. Following positive results from two Phase 3
trials (REVIVE-1 and REVIVE-2), a rolling submission of an NDA with
the U.S. 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. 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 believes, based on the data from the Phase
3 REVIVE studies, that iclaprim may be suitable for first-line
empiric therapy in ABSSSI patients, including those with renal
impairment, with or without diabetes.
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 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 has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track status.
Upon acceptance by the FDA of an 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.
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END
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