Motif Bio Presents New Iclaprim Data at IDWeek
03 Octobre 2018 - 9:01AM
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that iclaprim data are being presented
at IDWeek being held in San Francisco, CA, USA October 4-7, 2018.
The data show that iclaprim was non-inferior to vancomycin in a
pooled analysis of a subgroup of patients in the REVIVE Phase 3
trials who had wound infections. The results are being presented in
the Novel Agents poster abstract session on October 5th, 12:30 PM -
1:45 PM PT in poster #1338, 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.
A post-hoc analysis was conducted on the pooled
data from the REVIVE-1 and REVIVE-2 Phase 3 trials to evaluate the
safety and efficacy of iclaprim compared to vancomycin, the current
standard of care, in treating wound infections, including surgical
site infections. Fifty percent (602/1198) of the REVIVE
intent-to-treat (ITT) population had wound infections. Iclaprim
achieved non-inferiority to vancomycin, based on early clinical
response at the early time point in the subgroup of patients with
wound infections. Iclaprim and vancomycin had similar adverse event
profiles in patients with wound infections. Two vancomycin-treated
patients and no iclaprim-treated patients had serum creatinine
levels ≥3 x upper limit of normal, indicating potential
nephrotoxicity, a toxicity known to occur with vancomycin
administration.
G. Ralph Corey, MD, Vice Chair for
Education and Global Health and Gary Hock Professor at Duke
University School of Medicine and a principal investigator in the
REVIVE-2 trial, said: “Wound infections, including
surgical site infections, can be difficult to treat and it was
important to see that iclaprim was non-inferior to standard of care
in treating these types of infections. Additionally, in the
iclaprim treatment arm, there was no evidence of nephrotoxicity,
while two patients in the vancomycin arm demonstrated high serum
creatinine levels. Iclaprim, if approved, could be a valuable
treatment option for patients with wound infections suspected or
confirmed to be due to Gram-positive pathogens, including
patients with co-morbidities known to increase the risk of
vancomycin-associated acute kidney injury, such as renal
impairment, diabetes and obesity.”
The poster will be available in the Development
Programs – Publications section of Motif Bio’s website here:
www.motifbio.com/publications
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
(U.S. IR) |
+ 1
(646) 378-2963 |
Meggie Purcell |
mpurcell@troutgroup.com |
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Russo Partners
(U.S. PR) |
+1
(858) 717-2310 or +1 (212) 845 4272 |
David Schull |
david.schull@russopartnersllc.com |
Travis Kruse,
Ph.D. |
travis.kruse@russopartnersllc.com |
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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 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 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 recently received.
Notices of Allowance from the United States Patent and Trademark
Office for two method of use patents 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, 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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