Summit Highlights Utrophin Modulation as a Potential Universal Treatment Option in DMD at 15th Action Duchenne International ...
November 09 2017 - 7:00AM
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM) the drug discovery
and development company advancing therapies for Duchenne muscular
dystrophy (‘DMD’) and Clostridium difficile infection, announces
that the Company and collaborators from the University of Oxford
will highlight the potential of utrophin modulation as a universal
treatment for DMD in several presentations at the 15th Action
Duchenne International Conference 2017, taking place November
10-12, 2017, in Birmingham, UK. The conference brings together
families living with Duchenne and Becker muscular dystrophy, along
with experts and industry members aiming to treat these diseases.
The Company’s scientific adviser and co-founder,
Professor Kay Davies from the University of Oxford, will present
recently published preclinical data highlighting the benefits of
utrophin modulation on muscle health in animal models of DMD. The
data show that continuously expressing utrophin in a
dystrophin-deficient background can reduce mitochondrial aberration
and oxidative stress. Aberrant mitochondria drive, in part,
oxidative stress, which is a contributing factor to muscle damage
in DMD. In addition, Professor Davies is also expected to discuss
previously published preclinical data of utrophin modulators,
including ezutromid, that have shown these compounds’ potential to
prevent molecular disease, leading to functional improvements in
mdx mice.
Professor Kay Davies FRS of the
University of Oxford commented, “My team at the University
of Oxford continues to gather scientific evidence showing how
utrophin can substitute for dystrophin in animal muscle and prevent
many of the molecular hallmarks of DMD from occurring in these
animal models. Importantly, these underlying changes in muscle
health have the potential to lead to functional benefits, providing
hope for a universal, disease-modifying treatment for families
living with Duchenne.”
Separately, Summit’s presentations will focus on
the ongoing Phase 2 proof of concept clinical trial, PhaseOut DMD,
which is evaluating the Company’s lead utrophin modulator,
ezutromid. PhaseOut DMD is a 48-week open-label clinical trial that
is fully enrolled with a total of 40 patients with DMD. A key
milestone of this clinical trial is the 24-week assessment that
could provide initial clinical proof of mechanism for ezutromid and
these data are expected to be reported in the first quarter of
2018.
“These new preclinical data from Professor
Davies’ team at the University of Oxford provide another piece of
evidence highlighting the potential of utrophin modulation in being
able to treat this devastating muscle wasting disease,”
said Dr David Roblin, Chief Operating Officer and Medical
Officer at Summit. “We remain on-track to report the first
results of ezutromid treatment in boys with DMD in PhaseOut DMD in
the first quarter of 2018, and if results provide evidence of the
mechanism of utrophin modulation in patients, we believe it would
represent a major advancement for ezutromid. It would bring closer
to all patients a therapy that has the potential to be disease
modifying in DMD.”
About Utrophin Modulation in
DMDDMD 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 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 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)Erik Ostrowski / Michelle Avery (US office) |
Tel:
+44 (0)1235 443 951 +1 617 225 4455 |
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Cairn Financial Advisers LLP(Nominated
Adviser)Liam Murray / Tony Rawlinson |
Tel: +44 (0)20 7213 0880 |
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N+1 Singer (Broker)Aubrey Powell / Jen Boorer |
Tel: +44 (0)20 7496 3000 |
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MacDougall Biomedical Communications(US media
contact)Karen Sharma |
Tel:
+1 781 235 3060ksharma@macbiocom.com |
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Consilium
Strategic Communications (Financial public relations,
UK)Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Philippa
Gardner |
Tel: +44 (0)20 3709
5700 summit@consilium-comms.com |
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Summit Forward-looking
StatementsAny 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.
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