Summit Therapeutics plc Summit Highlights Scientific Rigour Of Its Phaseout Dmd Clinical Trial At Mda Clinical Conference
14 March 2018 - 10:00PM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
("Summit" or the "Company")
Summit Highlights Scientific Rigour of its PhaseOut DMD Clinical Trial
at MDA Clinical Conference
Oxford, UK, and Cambridge, MA, US, 14 March 2018 - Summit Therapeutics
plc (NASDAQ: SMMT, AIM: SUMM) highlighted the rigour being utilised in
the collection and analysis of muscle biopsies and magnetic resonance
spectroscopy ('MRS') related data in its PhaseOut DMD clinical trial, at
the 2018 MDA Clinical Conference in Arlington, VA.
PhaseOut DMD is a Phase 2 open-label trial of the Company's utrophin
modulator, ezutromid, in patients with Duchenne muscular dystrophy
('DMD'). Through this study, Summit is compiling a deep dataset for each
patient in the trial, which includes the analysis of several thousand
muscle fibres per biopsy sample. As part of this effort, steps are being
taken to remove human bias through the automated reading of biopsy and
MRS measurements at central sites.
"Since DMD is a muscle-wasting disorder, it is critical for us to have
high quality data from objective muscle health measurements as we assess
ezutromid's activity. As the collection of muscle biopsy and MRS
measurements are a major intervention for patients in clinical trials,
it means it is crucial this is done in a robust and reliable way," said
Dr David Roblin, Chief Medical Officer and President of R&D of Summit.
"Our data collection and analysis methods used in PhaseOut DMD helped
yield a high-quality dataset from all evaluable boys in the trial after
24-weeks of treatment. We are grateful to all the boys in the trial and
excited about the interim findings that showed compelling signs of
ezutromid activity."
The recently announced positive interim data from PhaseOut DMD showed
that after 24 weeks of treatment, there was a significant and meaningful
reduction in muscle damage, as well as a significant reduction in muscle
inflammation, in patients treated with ezutromid. These data provide
early evidence that ezutromid is modulating the production of utrophin
protein and having its intended effect of stabilising muscle membranes,
which has in turn led to early improvements in muscle health. Utrophin
is a protein that can substitute for dystrophin, the protein that is
missing in those with DMD the absence of which results in disease
progression and premature death. Because Summit's utrophin modulation
approach is independent of the patient's underlying dystrophin gene
mutation, it could be applicable to all patients with DMD.
Details of the Methodologies from the Poster Presentation
One of the methods being used to measure muscle damage in PhaseOut DMD
is biopsy analysis. Summit has made a significant effort to ensure that
these biopsies are handled, processed and analysed with great care. For
the biopsy procedure, two pieces of muscle are taken during each biopsy.
These pieces are frozen and shipped separately to a central reading
facility. Multiple sections from each biopsy are assayed for muscle
damage, yielding a total of six biopsy sections for each patient for
both the baseline and post-treatment samples. After quality control
checks, the muscle sections are then read via an automated system to
remove human bias. For the 24-week assessment, several thousand muscle
fibres were analysed per sample, producing a robust dataset for each
patient with high concordance across individual samples.
Muscle inflammation is measured by T2- relaxation time using MRS. MRS of
the soleus (calf) and vastus lateralis (thigh) muscles is performed at
central imaging centres following a training and certification process.
The MRS quantification is then performed by an automated blinded
process.
A copy of the poster is available in the Publications section of
Summit's website, www.summitplc.com.
About PhaseOut DMD
PhaseOut DMD is an open-label, multi-centre trial that has enrolled 40
patients in the US and UK, aged from their fifth to their tenth
birthdays. PhaseOut DMD is 48 weeks in length after which patients have
the option of enrolling into an extension phase and continuing to be
dosed with ezutromid. The primary endpoint is the change from baseline
in magnetic resonance spectroscopy parameters related to the leg
muscles. Biopsy measures evaluating utrophin and muscle damage are
included as secondary endpoints. Exploratory endpoints include the
six-minute walk distance, the North Star Ambulatory Assessment and
patient reported outcomes. Top-line 48-week results are expected to be
reported in the third quarter of 2018.
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 had 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 patient's underlying dystrophin
gene mutation. Summit also believes that utrophin modulation could be
complementary to other therapeutic approaches for DMD. The Company's
lead utrophin modulator, ezutromid, is an orally administered, small
molecule drug. 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 programmes 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).
Contacts
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 7213 0880
Liam Murray / Tony Rawlinson
N+1 Singer (Joint Broker) Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer
Panmure Gordon (Joint Broker) Tel: +44 (0)20 7886 2500
Freddy Crossley, Corporate Finance
Tom Salvesen, Corporate Broking
MacDougall Biomedical Communications (US) Tel: +1 781 235 3060
Karen Sharma ksharma@macbiocom.com
Consilium Strategic Communications (UK) Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Jessica Hodgson / summit@consilium-comms.com
Philippa Gardner
Summit Forward-looking Statements
Any statements in this press release about the Company's future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of the
Company's product candidates, the therapeutic potential of the Company's
product candidates, the potential commercialisation of the Company's
product candidates, the sufficiency of the Company's cash resources, the
timing of initiation, completion and availability of data from clinical
trials, the potential submission of applications for marketing approvals
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, laws and regulations affecting
government contracts, availability of funding sufficient for the
Company's foreseeable and unforeseeable operating expenses and capital
expenditure requirements and other factors discussed in the "Risk
Factors" section of filings that the Company makes with the Securities
and Exchange Commission, including the Company's Annual Report on Form
20-F for the fiscal year ended 31 January 2017. 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 the Company's views only as of the date of
this release and should not be relied upon as representing the Company's
views as of any subsequent date. The Company specifically disclaims any
obligation to update any forward-looking statements included in this
press release.
This announcement contains inside information for the purposes of
Article 7 of EU Regulation 596/2014 (MAR).
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contained therein.
Source: Summit Therapeutics plc via Globenewswire
http://www.summitplc.com/
(END) Dow Jones Newswires
March 14, 2018 07:00 ET (11:00 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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