Summit Therapeutics plc Summit Presents Preclinical Dmd Data At 21st Congress Of World Muscle Society
October 06 2016 - 7:00AM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
("Summit" or "the Company")
SUMMIT THERAPEUTICS PRESENTS PRECLINICAL DMD DATA AT THE 21(ST)
INTERNATIONAL CONGRESS OF THE WORLD MUSCLE SOCIETY
-- Summit reports on development of new, automated biomarker tools to
evaluate disease status of muscle biopsies
Oxford, UK, 6 October 2016 - Summit Therapeutics plc (AIM: SUMM, NASDAQ:
SMMT), the drug discovery and development company advancing therapies
for Duchenne muscular dystrophy ('DMD') and Clostridium difficile
infection, announces the presentation of preclinical data at the 21(st)
International Congress of the World Muscle Society, which is taking
place in Granada, Spain from 4-8 October 2016. The data include further
findings from Summit's programme to develop tools to measure biomarkers
of muscle health for use in patient clinical trials evaluating utrophin
modulator therapies.
"Our approach to DMD aims to maintain production of utrophin, a protein
typically found in young and repairing muscle fibres, so that it can
replace the missing dystrophin protein in mature muscle fibres,"
commented Dr Ralf Rosskamp, Chief Medical Officer of Summit. "The
development of new, fully automated biomarker tools capable of
evaluating the disease status of muscle biopsies will play an important
role in clinical trials, including our ongoing PhaseOut DMD trial. In
this trial, we seek to establish the potential of utrophin modulation,
including our most advanced candidate ezutromid, as an effective
treatment for all patients with this disease."
The findings reported at WMS highlight progress in the development of
fully automated quantification techniques for muscle biopsies capable of
measuring structural proteins such as utrophin and biomarkers of muscle
regeneration. The techniques described are immunohistochemical based
assays and digital tissue image analysis tools that can robustly measure
utrophin, beta-dystroglycan (a member of the dystrophin protein complex)
and developmental myosin (a biomarker of muscle fibre maturity) in
individual muscle fibres across a whole biopsy section.
Patients with DMD have higher levels of immature, regenerating muscle
fibres because the absence of dystrophin leads to a continual cycle of
muscle fibre damage and repair. By seeking to replace missing dystrophin
with utrophin, utrophin modulators such as ezutromid aim to maintain the
integrity of muscle fibres and allow them to mature. The automated
approaches described at WMS make it feasible to look at associations
between fibre maturity and integrity and utrophin expression in
individual fibres. This provides a basis to distinguish new and
beneficial expression of utrophin caused by a utrophin modulating drug,
from the expression of utrophin seen generally during fibre
regeneration. This is an important step in understanding and
characterising the activity of these drugs.
This biomarker research is being conducted in partnership with Flagship
Biosciences using their computational Tissue Analysis (cTA(TM)) approach
to accelerate precise muscle fibre biomarker quantification. This work
builds on a recently published manual quantification approach that was
developed by Summit and researchers at the Institute of Child Health,
London with financial support from the charity Joining Jack. Further
validation work to optimise the Flagship Biosciences' cTA(TM) approach
is ongoing; it is expected the tools will be used in Summit's Phase 2
proof of concept trial of ezutromid, PhaseOut DMD.
Additional presentations at WMS 2016 reported preclinical data
highlighting the potential of utrophin modulation as a disease-modifying
treatment for all patients with DMD, regardless of the underlying fault
in the dystrophin gene. This research was conducted at the University of
Oxford under the UtroDMD alliance.
Copies of the presentations given at WMS 2016 are available from the
'Programmes' section of Summit's website, www.summitplc.com.
About PhaseOut DMD
PhaseOut DMD aims to provide proof of concept for ezutromid and utrophin
modulation by measuring muscle fat infiltration, as well as by measuring
utrophin protein and muscle fibre regeneration in muscle biopsies. The
primary endpoint of the open-label trial is the change from baseline in
magnetic resonance imaging parameters related to fat infiltration and
inflammation of the leg muscles. Exploratory endpoints include the
six-minute walk distance, the North Star Ambulatory Assessment and
patient reported outcomes. PhaseOut DMD is a 48-week open-label trial
expected to enrol up to 40 boys ranging in age from their fifth to their
tenth birthdays at sites in the UK and the US.
Further information is available at: www.utrophintrials.com and
https://clinicaltrials.gov/ct2/show/NCT02858362.
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that affects around 50,000
boys and young men in the developed world. The disease is caused by
different genetic faults in the gene that encodes dystrophin, a protein
that is essential for the healthy function of all muscles. There is
currently no cure for DMD and life expectancy is into the late twenties.
Utrophin protein is functionally and structurally similar to dystrophin.
In preclinical studies, the continued expression of utrophin has a
meaningful, positive effect on muscle performance. Summit believes that
utrophin modulation has the potential to slow down or even stop the
progression of DMD, regardless of the underlying dystrophin gene
mutation. Summit also believes that utrophin modulation could
potentially be complementary to other therapeutic approaches for DMD.
The Company's lead utrophin modulator, ezutromid, is an orally
administered, small molecule. DMD is an orphan disease, and the US Food
and Drug Administration ('FDA') and the European Medicines Agency have
granted orphan drug status to ezutromid. Orphan drugs receive a number
of benefits including additional regulatory support and a period of
market exclusivity following approval. In addition, ezutromid has been
granted Fast Track designation and Rare Pediatric Disease designation by
the FDA.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery,
development and commercialisation of novel medicines for indications for
which there are no existing or only inadequate therapies. Summit is
conducting clinical programs focused on the genetic disease Duchenne
muscular dystrophy and the infectious disease C. difficile infection.
Further information is available at www.summitplc.com and Summit can be
followed on Twitter (@summitplc).
For more information, please contact:
Summit
Glyn Edwards / Richard Pye (UK office) Tel: +44 (0)1235 443 951
Erik Ostrowski / Michelle Avery (US office) +1 617 225 4455
Cairn Financial Advisers LLP
(Nominated Adviser) Tel: +44 (0)20 7148 7900
Liam Murray / Tony Rawlinson
N+1 Singer
(Broker) Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer
MacDougall Biomedical Communications
(US media contact) Tel: +1 781 235 3060
Chris Erdman / Karen Sharma cerdman@macbiocom.com /
ksharma@macbiocom.com
Consilium Strategic Communications Tel: +44 (0)20 3709 5700
(Financial public relations, UK) summit@consilium-comms.com
Mary-Jane Elliott / Sue Stuart /
Jessica Hodgson / Lindsey Neville
Forward-looking Statements
Any statements in this press release about Summit's future expectations,
plans and prospects, including but not limited to, statements about the
clinical and preclinical development of Summit's product candidates, the
utility of tools developed to evaluate Summit's product candidates, the
therapeutic potential of Summit's product candidates, and the timing of
initiation, completion and availability of data from clinical trials,
and other statements containing the words "anticipate," "believe,"
"continue," "could," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project," "should," "target," "would," and
similar expressions, constitute forward looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important factors,
including: the uncertainties inherent in the initiation of future
clinical trials, availability and timing of data from ongoing and future
clinical trials and the results of such trials, whether preliminary
results from a clinical trial will be predictive of the final results of
that trial or whether results of early clinical trials or preclinical
studies will be indicative of the results of later clinical trials,
expectations for regulatory approvals, availability of funding
sufficient for Summit's foreseeable and unforeseeable operating expenses
and capital expenditure requirements and other factors discussed in the
"Risk Factors" section of filings that Summit makes with the Securities
and Exchange Commission including Summit's Annual Report on Form 20-F
for the fiscal year ended January 31, 2016. Accordingly readers should
not place undue reliance on forward-looking statements or information.
In addition, any forward-looking statements included in this press
release represent Summit's views only as of the date of this release and
should not be relied upon as representing Summit's views as of any
subsequent date. Summit specifically disclaims any obligation to update
any forward-looking statements included in this press release.
--
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The issuer of this announcement warrants that they are solely
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contained therein.
Source: Summit Therapeutics plc via Globenewswire
http://www.summitplc.com/
(END) Dow Jones Newswires
October 06, 2016 07:00 ET (11:00 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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