Motif Bio plc (AIM:MTFB) (Nasdaq:MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announces that the Company will host an Investor
and Analyst Event on Wednesday, September 20, 2017, in New York
from 8:00 am – 10:00 am ET, 1.00pm – 3.00pm UK time, 2.00pm
– 4.00pm CET.
The event will focus on describing the unmet
needs of hospitalised patients with serious and life-threatening
infections and highlight the key attributes of iclaprim that, if
approved, may offer advantages over current standard of care
antibiotics in three well-defined groups of patients.
A faculty of infectious disease experts and
Motif Bio senior management will describe the clinical and economic
challenges that can lead to poor outcomes in high-risk,
difficult-to-treat hospitalised patients with serious infections.
The potential role that iclaprim can play in these patients will be
described.
The agenda will include:
Introduction Graham G. Lumsden, Chief Executive
Officer, Motif Bio Iclaprim Overview & REVIVE-1 (Ph. 3)
Results David Huang, PhD, MD, Chief Medical
Officer, Motif Bio William D. O’Riordan, MD, FACEP, Chief
Medical Officer, eStudySite, San Diego, CA
HABP Treatment Considerations & Unmet Needs
Thomas M. File, Jr., MD, MSc, MACP, FIDSA, FCCP Chair, Infectious
Disease Division, Summa Health, Akron, OH
Challenges in Managing Hospitalised ABSSSI Patients with
Renal Impairment Francis Natale, PharmD, Director of
Pharmacy, Methodist Hospital Division, Thomas Jefferson University
Hospitals, Philadelphia, PA Thomas Holland, MD, MSc-GH, Duke
University School of Medicine & Clinical Research Institute,
Durham, NCEconomic Burden of High Risk Hospitalised ABSSSI
Patients Tom Lodise, PhD, PharmD, Albany College of
Pharmacy & Health Sciences, Albany, NY
Commercial Market Opportunity Lynda Berne,
M.S., M.B.A., Commercial Head, Motif Bio
If you are a member of the investment community
and would like to attend, please contact ir@motifbio.com.
The presentation will be webcast simultaneously
and accessible through the Investors - Events & Presentations
section of the Company’s website at www.motifbio.com. A webcast
replay, including slides, will be available for 30 days following
the event.
Note to Editors
About Motif Bio
Motif Bio plc (AIM:MTFB) (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 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. 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 on
October 6, 2017 in San Diego. 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 U.S. 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 StatementsThis
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.
For further information please contact:
Motif Bio plc
info@motifbio.com
Graham Lumsden (Chief Executive Officer)
Robert Dickey IV (Chief Financial Officer)
Walbrook PR Ltd. (UK FINANCIAL PR & IR)
+44 (0) 20 7933 8780 / 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
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