Summit Presents Data From Phase 1 Clinical Programme of Ezutromid at the European Paediatric Neurology Society Congress
22 Juin 2017 - 1:00PM
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 the presentation of clinical data from two Phase 1
clinical trials of ezutromid, Summit’s lead utrophin modulator, at
the European Paediatric Neurology Society Congress in Lyon, France.
The oral presentation focussed on the Company’s positive efforts to
improve absorption and increase exposure of ezutromid in patients
with DMD, as evidenced by the results of both the modified diet and
new formulation Phase 1 clinical trials. The presentation took
place today, 22 June 2017, during the Neuromuscular Pathologies 2
session.
“Our Phase 1 clinical development programme has
identified ways to improve the pharmacokinetic profile of
ezutromid. Through both formulation development and dietary advice,
ezutromid achieves exposures which we believe have the potential to
sustain utrophin production in patients with DMD,”
commented Dr David Roblin, President of R&D of
Summit. “We are now utilising both methods in our ongoing
Phase 2 clinical trial, PhaseOut DMD, where we have the chance to
see the impact of ezutromid drug exposure on pharmacology, safety
and efficacy with longer term dosing of patients with DMD.”
The presentation is available on the
Publications page of Summit’s website, www.summitplc.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 / Lauren Kettle |
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Tel: +44 (0)20 7496
3000 |
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MacDougall
Biomedical Communications(US media contact)Karen
Sharma |
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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 / Lindsey
Neville |
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Tel: +44 (0)20 3709 5700
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, 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, 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 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.
-END-
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