Motif Bio to Present Iclaprim Data at Upcoming Scientific Conferences
20 Septembre 2018 - 8:00AM
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 2018October 3-7,
2018San 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, 2018Room: S Poster Hall
The abstract is now available on the IDWeek
website here.
World Anti-Microbial Resistance
CongressOctober 25-26,
2018Washington, 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) |
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|
|
Walbrook PR
Ltd. (UK FINANCIAL PR & IR) |
+44 (0) 20 7933 8780 |
Paul McManus/Helen
Cresswell/Lianne Cawthorne |
|
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MC Services AG
(EUROPEAN IR) |
+49 (0)89 210 2280 |
Raimund Gabriel |
raimund.gabriel@mc-services.eu |
|
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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.
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