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 the European Society of Clinical Microbiology and Infectious
Diseases (ESCMID)/American Society for Microbiology (ASM)
Conference on Drug Development to Meet the Challenge of
Antimicrobial Resistance being held in Lisbon, Portugal, September
4-7, 2018.
The Safety of Iclaprim among Diabetic Patients
for the Treatment of Acute Bacterial Skin and Skin Structure
Infections (ABSSSI): Pooled REVIVE StudiesA post-hoc analysis was
conducted on the pooled data from the REVIVE-1 and REVIVE-2 trials
to evaluate the safety of iclaprim compared to vancomycin, the
current standard of care, in treating ABSSSI patients with
diabetes. Eleven percent (127/1198) of the REVIVE
intent-to-treat (ITT) population had diabetes, and renal impairment
was common among these patients, 39.2% (22/56) in the iclaprim
group and 36.6% (26/71) in the vancomycin group. Overall
adverse events in diabetic patients treated with iclaprim (48.2%)
were lower compared to vancomycin (52.9%) and there were fewer
treatment-related AEs – iclaprim (8.9%) versus vancomycin (15.7%).
No patients with diabetes who were treated with iclaprim developed
acute kidney injury/increased blood creatinine levels, compared to
three diabetic patients in the vancomycin arm. Discontinuation of
study drug due to an AE was reported in 3.6% (2/56) of patients
with diabetes treated with iclaprim versus 10.0% (7/70) treated
with vancomycin.
Thomas L. Holland, M.D., MSc-GH,
Assistant Professor of Medicine, Duke University School of
Medicine, said: “Diabetes is a risk factor for ABSSSI and
for vancomycin-associated acute kidney injury. Patients with
diabetes have worse outcomes with increased clinical failures and
longer hospitalisations than patients who do not have diabetes. In
the pooled REVIVE ITT population, about 11% of patients had
diabetes, and more than a third of those with diabetes had renal
impairment. These patients may be particularly vulnerable to
vancomycin-related side effects, including kidney toxicity. If
approved, iclaprim may be an important new option to treat this
patient group.”
Data evaluating the activity of iclaprim in a
variety of bacteria, including drug-susceptible versus
drug-resistant strains were also presented at the conference. This
included:
Iclaprim Activity Against Clinical Isolates
Causing Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
in the Phase 3 REVIVE-1 and REVIVE-2 Studies: An evaluation of the
activity of iclaprim against clinical isolates causing ABSSSI in
the REVIVE trials, demonstrating that iclaprim had potent in vitro
activity against S. aureus, including MRSA.
Surveillance of Iclaprim Activity: In Vitro
Susceptibility of Drug-Susceptible and Resistant Beta-hemolytic
Streptococci Collected During 2012-2016 from Skin and Skin
Structure Infections: An evaluation of iclaprim against both
drug-susceptible and drug-resistant strains of S. pyogenes and S.
agalactiae (samples from patients with ABSSSI collected worldwide
during 2012-2016). Data showing iclaprim’s activity had previously
been from samples collected prior to 2006. Iclaprim was shown to be
active in vitro against these newer strains.
Surveillance of Iclaprim Activity: In Vitro
Susceptibility of Gram-Positive Skin and Skin Structure Pathogens
Collected During 2004-2016: An evaluation of iclaprim against
Gram-positive clinical isolates, including S. aureus (MSSA and
MRSA) and beta-hemolytic streptococci collected from patients with
ABSSSI between 2004 and 2016. Iclaprim had consistent in vitro
activity against these isolates and was shown to be more potent
than trimethoprim alone and equally potent compared to
trimethoprim-sulfamethoxazole. Iclaprim also had greater potency
than standard of care Gram-positive antibiotics such as vancomycin,
linezolid and daptomycin against MRSA.
Additionally, David Huang, MD, Chief Medical
Officer of Motif Bio, is giving a presentation on iclaprim as part
of the State of the Art Lecture: New Antibacterial
Agents. In his presentation, Dr. Huang provides an
overview of iclaprim data in ABSSSI. A New Drug Application for
iclaprim in the treatment of ABSSSI is currently under review at
the U.S. Food and Drug Administration (FDA) with a target action
date under the Prescription Drug User Fee Act (PDUFA) of
February 13, 2019.
Dr. Huang said: “Given the
worldwide crisis in antibiotic resistance, there remains a major
need for new antibiotic treatments. We have shown comprehensive
data indicating that iclaprim has potent activity against a
wide variety of Gram-positive bacteria, including MRSA, that cause
severe skin infections. With its targeted Gram-positive spectrum of
activity, low propensity for resistance development, favourable
tolerability profile and efficacy results, we think that, if
approved, iclaprim could be an important new treatment option for
patients with ABSSSI, Including patients with co-morbidities such
as diabetes, renal impairment and obesity.”
The posters and presentation will be available
in the Development Programs – Publications section of Motif Bio’s
website.
For further information please contact:
|
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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 |
|
|
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 |
|
|
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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