Motif Bio PLC Appointment of Vice President,Clinical Development
09 Maggio 2018 - 8:01AM
RNS Non-Regulatory
TIDMMTFB
Motif Bio PLC
09 May 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Appoints Stephanie Noviello, MD, MPH as Vice
President, Clinical Development
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that Stephanie Noviello, MD, MPH has
joined the Company as Vice President, Clinical Development. She
will report to David Huang, MD, PhD, Chief Medical Officer. Dr.
Noviello will be a key contributor to the European Marketing
Authorisation Application submission for iclaprim.
Dr. Noviello joins Motif Bio from Bristol-Myers Squibb, where
she most recently was Clinical Program Lead, Virology. In this
position, she served as clinical lead for the hepatitis B and C and
HIV portfolios. She previously worked at Schering-Plough Research
Institute as a Director in Hepatology. Prior to working in
industry, she was an Epidemic Intelligence Service Officer at the
US Centers for Disease Control and Prevention stationed with the
New York State Department of Health Bureau of Communicable Disease
Control. Dr. Noviello has extensive experience in developing
clinical trial protocols, overseeing large trials and effectively
interacting with regulatory agencies. She is also a board-certified
pediatrician. Dr. Noviello received her MD from Tulane University
School of Medicine and her MPH from the Tulane University School of
Public Health and Tropical Medicine. She received a BA in Chemistry
from Cornell University.
David Huang, MD, PhD, Chief Medical Officer of Motif Bio, said:
"We are delighted to have Stephanie join Motif. Her strategic
insights, experience and leadership in late-stage global clinical
trials and the regulatory process, including post-marketing
requirements, make her ideally suited for this position. I am very
excited and am looking forward to working with Stephanie as we
continue to progress iclaprim towards an approval."
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 that has a
different and underutilised mechanism of action compared to 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 patients with renal impairment due
to efficacy and/or safety issues. No kidney toxicity was observed
with iclaprim in the REVIVE Phase 3 trials.
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 ABSSSI has been initiated and is
expected to be completed in the second quarter of 2018. ABSSSI is
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.
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 company news service from the London Stock Exchange
END
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May 09, 2018 02:01 ET (06:01 GMT)
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