TIDMMTFB
Motif Bio PLC
05 September 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Presents Iclaprim Data at ESCMID/ASM Conference
-- Iclaprim overview presented in State of the Art Lecture
-- Safety analysis of diabetic patients in REVIVE ABSSSI trials
shows fewer adverse events versus vancomycin
-- Surveillance data confirm in vitro activity of iclaprim
against wide variety of Gram-positive bacteria, including
drug-resistant strains
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 Studies
A 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:
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 (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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END
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