Motif Bio to Present Iclaprim Data at ECCMID 2019
April 04 2019 - 2:00AM
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announced today that four iclaprim abstracts have been
accepted for presentation at the upcoming 28th European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID 2019) to be
held in Amsterdam, The Netherlands, April 13-16, 2019.
ECCMID brings together leading experts in the
infectious diseases, infection control and clinical microbiology
sector to present and discuss the latest results.
Details for each presentation and poster are
noted below, including links to the related abstracts, which are
available at https://www.eccmidlive.org.
- An efficacy analysis by lesion size of iclaprim versus
vancomycin in patients with acute bacterial skin and skin structure
infections: pooled phase III REVIVE trials
(#O0303)Session type: Mini
oral e-poster session Session: Clinical
trials with recently approved or late-stage development
antibioticsDate and Time: April 13, 2019,
2:45-3:45 PMThe link to the abstract is available here.
- Surveillance of iclaprim activity against
Gram-positive cocci, including antibiotic-resistant strains,
collected from patients with skin and skin structure infections
during 2017 from European and American hospitals
(#P1884)Session type: Paper
posterSession name: In vitro activity of
newer antibacterial agentsDate and time:
April 15, 2019, 1:30-2:30 PMThe link to the abstract is available
here.
- Iclaprim versus vancomycin for patients with
acute bacterial skin and skin structure infection complicated by
Staphylococcus aureus or streptococcal bacteraemia: a pooled
analysis of the phase III REVIVE trials
(#P2287)Session type: Paper
posterSession name: Skin and soft tissue
infectionsDate and time: April 16, 2019,
12:30-1:30 PMThe link to the abstract is available here.
- Pharmacokinetics of iclaprim by age, weight,
race and renal/hepatic function in patients with acute bacterial
skin and skin structure infections: phase III REVIVE trials
(#O1162)Session type: Oral
session Session: PK/PD to guide dosing in
special populationsDate and Time: April 16, 2019,
1:30 PM-3:30 PMThe link to the abstract is available here.
Additionally, an abstract on results from a
study on the real-world incidence of vancomycin-associated
nephrotoxicity in patients hospitalised with ABSSSI will be
presented by Michael J. Rybak, PharmD, MPH, FCCP, BCPS, Associate
Dean for Research, Professor of Pharmacy and Medicine Director, The
Anti-Infective Research Laboratory, Eugene Applebaum College of
Pharmacy and Health Science, Wayne State University:
Real-world incidence of
vancomycin-associated nephrotoxicity in hospitalised patients with
acute bacterial skin and soft structure infections
(#P2297)
Session type: Paper
posterSession: Skin and soft tissue
infectionsDate and Time: April 16, 2019,
12:30-1:30 PM
The link to the abstract is available here.
For further information please contact:
Motif Bio plc |
ir@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 |
motifbio@walbrookpr.com |
|
|
MC
Services AG (EUROPEAN IR) |
+49 (0) 89
210 2280 |
Raimund
Gabriel |
raimund.gabriel@mc-services.eu |
|
|
Russo Partners (U.S. PR) |
+1 (858)
717-2310 or +1 (212) 845 4272 |
David
Schull |
david.schull@russopartnersllc.com |
Note to Editors:
About Motif BioMotif Bio plc
(AIM/NASDAQ: MTFB) is a clinical-stage biopharmaceutical company
focused on developing novel antibiotics 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. Motif Bio is seeking
approval of iclaprim from 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 has 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 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. Motif is also building a patent estate to
provide additional protection for iclaprim and has two U.S. method
of use patents issued that will expire in 2037.
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, (x) Motif Bio’s ability to raise additional
capital to sustain its operations and pursue its strategy and (xi)
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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