Summit Receives Fast Track Designation From US FDA for Ezutromid in the Treatment of Duchenne Muscular Dystrophy
26 Septembre 2016 - 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 it has received Fast Track designation from the US
Food and Drug Administration (‘FDA’) for ezutromid in the treatment
of DMD. Ezutromid is a utrophin modulator and represents a
potential disease modifying treatment for all patients with the
fatal muscle wasting disease DMD.
“Fast Track designation underscores the
importance that the FDA places on developing new treatments for
life-threatening disorders, such as DMD, and aligns well with our
recently outlined strategy to accelerate the development of
ezutromid to market,” said Glyn Edwards, Chief Executive
Officer of Summit. “As a utrophin modulator, ezutromid has
the potential to significantly advance the state of care for all
patients with DMD, regardless of their underlying genetic fault. We
look forward to ezutromid’s continued progress in our ongoing Phase
2 clinical trial, PhaseOut DMD.”
Fast Track is a process designed to facilitate
the development and expedite the review of drugs to treat serious
conditions that address an unmet medical need. Advantages of Fast
Track designation include opportunities for more frequent
interactions with the FDA during all aspects of development,
submission of a New Drug Application (‘NDA’) on a rolling basis,
and eligibility for accelerated approval and priority review. This
designation is in addition to ezutromid being granted Orphan Drug
designation by the FDA and the European Medicines Agency.
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 designation 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 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).
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.
-END-
For more information, please contact:
Summit
Glyn Edwards / Richard Pye (UK office)
Tel: +44 (0)1235 443 951
Erik Ostrowski / Michelle Avery (US office)
Tel: +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)
Chris Erdman / Karen Sharma
Tel: +1 781 235 3060
cerdman@macbiocom.com /
ksharma@macbiocom.com
Consilium Strategic Communications
(Financial public relations, UK)
Mary-Jane Elliott / Sue Stuart /
Jessica Hodgson / Lindsey Neville
Tel: +44 (0)20 3709 5700
summit@consilium-comms.com
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