Motif Bio PLC Motif Bio Submits NDA for Iclaprim (3431R)
14 Giugno 2018 - 8:00AM
UK Regulatory
TIDMMTFB
RNS Number : 3431R
Motif Bio PLC
14 June 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Submits NDA for Iclaprim
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced the completion of its rolling
submission of a New Drug Application (NDA) to the U.S. Food &
Drug Administration (FDA) for iclaprim, a targeted, Gram-positive
investigational antibiotic, for the treatment of acute bacterial
skin and skin structure infections (ABSSSI).
"The NDA submission for iclaprim is a major milestone for Motif
Bio. Our team of experts has worked tirelessly to achieve this
important goal," said Graham Lumsden, Chief Executive Officer. "We
look forward to working with the FDA with the goal of bringing this
antibiotic candidate to patients as expeditiously as possible."
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track
Designation. Upon acceptance of the filing of the NDA by the FDA,
iclaprim will receive Priority Review, a review period of six
months instead of the standard ten months. If iclaprim is approved
as a new chemical entity with QIDP designation, it will be eligible
for 10 years of market exclusivity in the U.S. starting from the
date of approval.
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief Executive 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
David Hignell/John Howes/Rob Rees
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 (U.S. IR) + 1 (646) 378-2936
Meggie Purcell mpurcell@troutgroup.com
Russo Partners (U.S. 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 New Drug Application
(NDA) has been submitted to the U.S. Food & Drug Administration
(FDA) for the treatment of acute bacterial skin and skin structure
infections (ABSSSI). 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), an NDA has been submitted to the
U.S. FDA for the treatment of acute bacterial skin and skin
structure infections (ABSSSI). 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.
This information is provided by RNS, the news service of the
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