Summit Presents New 24-Week Analyses from PhaseOut DMD at the 2018 American Academy of Neurology Annual Meeting
April 20 2018 - 7:00AM
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM) announces the
presentation of new 24-week interim analyses from PhaseOut DMD, a
Phase 2 open-label, multi-centre clinical trial of the utrophin
modulator ezutromid in Duchenne muscular dystrophy (‘DMD’), at the
70th American Academy of Neurology Annual Meeting (‘AAN’). These
new analyses showed a high correlation between reductions in
developmental myosin, a biomarker of muscle damage which was
measured by muscle biopsy, and reductions in muscle inflammation,
which was measured by magnetic resonance, in patients after 24
weeks of ezutromid treatment. These findings underpin existing
evidence that by modulating utrophin protein production, ezutromid
is reducing the severity of DMD.
“The correlation observed between decreases in
developmental myosin, a biomarker of muscle damage, and decreases
in muscle fibre inflammation, is highly encouraging, and we believe
further supports that ezutromid is breaking the DMD disease cycle
of muscle damage and repair,” commented Dr David Roblin,
Chief Medical Officer and President of R&D of Summit.
“We look forward to reporting the full results of this trial,
expected in the third quarter of 2018.”
The presentation was selected for the Emerging
Science dual oral and poster presentation at AAN and authored by
Professor Francesco Muntoni on behalf of the PhaseOut DMD Study
Group, Gary Layton, Indranil Bhattacharya, Crystal Faelan, Anne C
Heatherington, David Roblin, Jon Tinsley, and Professor Kay E
Davies. A copy of the late-breaking presentation is available on
Summit’s website, www.summitplc.com.
About PhaseOut DMDPhaseOut 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 parameters related to the leg
muscles. Biopsy measures evaluating utrophin and muscle damage are
included as secondary endpoints, with patients having two biopsies:
one at baseline and their second after either 24 weeks or 48 weeks
of ezutromid treatment. 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 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 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 |
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MacDougall Biomedical Communications (US) |
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Karen
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ksharma@macbiocom.com |
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Mary-Jane Elliott / Jessica Hodgson / |
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summit@consilium-comms.com |
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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, the timing of initiation, completion and
availability of data from clinical trials, the potential submission
of applications for regulatory approvals, the sufficiency of
Summit’s cash resources, 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, 2018. 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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