TIDMMTFB
RNS Number : 6791X
Motif Bio PLC
14 August 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Announces FDA Acceptance of New Drug Application with
Priority Review
for Iclaprim for Treatment of Acute Bacterial Skin and Skin
Structure Infections
-- PDUFA action date set for February 13, 2019
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that the U.S. Food & Drug
Administration (FDA) has accepted for filing the New Drug
Application (NDA) for iclaprim, a targeted, Gram-positive
investigational antibiotic, for the treatment of acute bacterial
skin and skin structure infections (ABSSSI). This means that the
FDA has determined that the application is sufficiently complete to
perform a substantive review. The NDA has been granted Priority
Review, and the FDA has set a target decision date under the
Prescription Drug User Fee Act (PDUFA) of February 13, 2019.
"The NDA acceptance by the FDA is an important milestone for
Motif Bio and reflects the dedication and commitment of our team
who have worked tirelessly to accomplish this," said Graham
Lumsden, Chief Executive Officer of Motif Bio. "We believe that, if
approved, iclaprim could be an important new treatment option for
patients with serious skin infections. We look forward to working
closely with the FDA as we move through the review process with the
goal of bringing iclaprim to patients as quickly as possible."
More than 3.6 million patients with ABSSSI are hospitalised
annually in the U.S. It is estimated that up to 26% of hospitalised
ABSSSI patients have renal impairment. Hospitalised patients with
obesity, diabetes and/or poor kidney function are particularly
vulnerable to vancomycin-associated kidney injury. Many standard of
care Gram-positive antibiotics are not suitable for treatment of
hospitalised ABSSSI patients with these conditions due to efficacy
and/or safety issues.
The NDA includes data from two Phase 3 trials (REVIVE-1 and
REVIVE-2) evaluating iclaprim for the treatment of patients with
ABSSSI. In both trials, 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 endpoint, 7 to 14 days after study
drug discontinuation, in the ITT patient population.
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA. 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, under the Generating Antibiotic Incentives Now Act (the
GAIN Act).
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)20 3861 6625
David Hignell/Vadim Alexandre/Rob
Rees
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0)20 7933 8780
Paul McManus/Helen Cresswell/Lianne motifbio@walbrookpr.com
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) 378-2963
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
hospitalised 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 Gram-positive 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 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). 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 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. If
approved as a New Chemical Entity, iclaprim 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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