TIDMMTFB
Motif Bio PLC
03 October 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Presents New Iclaprim Data at IDWeek
-- Iclaprim safety and efficacy in patients with wound infections in REVIVE Phase 3 trials
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 5(th) , 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)
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
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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