Summit Enrols Patients in the United States Into PhaseOut DMD, a Phase 2 Clinical Trial of Ezutromid in Patients With DMD
16 November 2016 - 11:00PM
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy (‘DMD’) and Clostridium difficile infection,
today announces that it has enrolled its first patients at trial
sites in the US into PhaseOut DMD, a Phase 2 proof of concept
clinical trial of ezutromid in patients with DMD. Ezutromid dosing
is expected to follow within a screening period of up to 28 days.
Enrolment and dosing of patients into PhaseOut DMD in the UK is
ongoing. Ezutromid is a utrophin modulator and represents a
potential disease modifying treatment for all patients with DMD.
“Ezutromid has shown great promise in
preclinical testing as a universal treatment that has the potential
to slow or stop disease progression in all patients with DMD,
regardless of their underlying dystrophin gene mutation,”
said John Jefferies, MD, of Cincinnati Children’s Hospital
Medical Center, and the US coordinating investigator in PhaseOut
DMD. ”We are excited to participate in PhaseOut DMD and
contribute to the clinical development of this utrophin
modulator.”
Ralf Rosskamp, MD, Chief Medical Officer
of Summit added, “Our PhaseOut DMD clinical trial is an
important component of bringing ezutromid to patients and families
who are in urgent need of a disease modifying therapy, and we are
making progress with patient enrolment in this clinical trial, with
enrolment ongoing in the UK and now in the US.”
This announcement contains inside information
for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
About PhaseOut DMDPhaseOut 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. Each patient will receive two biopsies,
one at baseline and the second either at 24 or 48 weeks. Data from
the initial group of 24-week biopsies are expected Q2/Q3 2017.
Further information is available at:
https://clinicaltrials.gov/ct2/show/NCT02858362 and
www.utrophintrials.com.
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)Erik Ostrowski / Michelle Avery (US office) |
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Tel: +44
(0)1235 443 951 +1 617 225 4455 |
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Cairn Financial Advisers LLP(Nominated
Adviser)Liam Murray / Tony Rawlinson |
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Tel: +44 (0)20 7213 0880 |
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N+1 Singer (Broker)Aubrey Powell / Jen
Boorer |
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Tel: +44 (0)20 7496 3000 |
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MacDougall Biomedical Communications(US media
contact)Chris Erdman / Karen Sharma |
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Tel: +1
781 235 3060cerdman@macbiocom.comksharma@macbiocom.com |
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Consilium
Strategic Communications (Financial public relations,
UK)Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Lindsey
Neville |
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Tel: +44 (0)20 3709 5700
summit@consilium-comms.com |
Forward-looking StatementsAny
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 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
on-going 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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