TIDMMTFB
Motif Bio PLC
20 September 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio to Present Iclaprim Data at Upcoming Scientific
Conferences
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that iclaprim data will be presented
at two upcoming scientific conferences.
IDWeek 2018
October 3-7, 2018
San Francisco, CA USA
Iclaprim data will be presented at the conference in a poster,
entitled: A Pooled Analysis of Patients with Wound Infections in
the Phase 3 REVIVE Trials: Randomized, Double-blind Studies to
Evaluate the Safety and Efficacy of Iclaprim Versus Vancomycin for
treatment of Acute Bacterial Skin and Skin Structure Infections
(#1338)
Poster Session: Novel Agents
Date: Friday, October 5, 2018
Room: S Poster Hall
The abstract is now available on the IDWeek website here.
World Anti-Microbial Resistance Congress
October 25-26, 2018
Washington, DC USA
David Huang, MD, PhD, Chief Medical Officer of Motif Bio, will
deliver a keynote address on October 25 entitled: Updates to
Iclaprim clinical development program.
The congress provides a platform to discuss critical challenges
and opportunities to advance antibiotic and diagnostics
development, improve antimicrobial stewardship practice and
incentivize funding and partnering to bring innovation to patients
and the healthcare system in need. This antimicrobial
resistance-focused event attracts over 150 speakers and 400
attendees from more than 20 countries. The agenda for the congress
can be found here.
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) 378-2963
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 New Drug Application
(NDA) was submitted to the U.S. Food & Drug Administration
(FDA) for the treatment of acute bacterial skin and skin structure
infections (ABSSSI) and is now under review, with a PDUFA date of
February 13, 2019. 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 the REVIVE 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) was submitted to the U.S. Food & Drug Administration
(FDA) for the treatment of acute bacterial skin and skin structure
infections (ABSSSI) and is now under review, with a PDUFA date of
February 13, 2019. 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 for
the ABSSSI indication. If approved for the ABSSSI indication ,
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRALLFLLAEIALIT
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September 20, 2018 02:01 ET (06:01 GMT)
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