First Patient Enrolled in Summit’s PhaseOut DMD, a Phase 2 Clinical Trial of Ezutromid in Boys With DMD
June 17 2016 - 6:00AM
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 the first patient in PhaseOut
DMD, a Phase 2 proof of concept clinical trial of ezutromid
(formerly SMT C1100) in patients with DMD. Ezutromid dosing is
expected to follow a screening period of up to 28 days.
Ezutromid is an orally administered small
molecule that is designed to modulate utrophin, a protein that is
structurally and functionally similar to the dystrophin protein.
Dystrophin is essential for the healthy function of all muscles but
is missing in patients with DMD. Utrophin modulation is a potential
disease-modifying approach that could treat all boys and young men
with DMD, regardless of their underlying dystrophin gene
mutation.
“Ezutromid has garnered considerable interest
from the patient, family and healthcare communities, which we
believe is due to its potential to slow or stop progression of DMD
regardless of the underlying dystrophin gene mutation,”
said Ralf Rosskamp, MD, Chief Medical Officer of
Summit. “The enrolment of the first patient in PhaseOut
DMD is a significant milestone in the clinical development of
ezutromid, with the aim of studying long-term dosing of ezutromid
in boys with DMD. We look forward to the possibility of
demonstrating ezutromid’s effect on utrophin with the initial set
of 24-week biopsy data.”
The Company anticipates reporting data
periodically during this trial with 24-week muscle biopsy data from
the first group of patients enrolled expected to be reported in
January 2017.
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.
Further information is available at:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004333-27/GB.
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 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.
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) |
|
Liam
Murray / Tony Rawlinson |
Tel: +44
(0)20 77148 7900 |
|
|
N+1 Singer |
|
(Broker) |
|
Aubrey
Powell / Jen Boorer |
Tel: +44
(0)20 7496 3000 |
|
|
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 |
|
|
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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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