Summit’s IND Cleared by FDA Allowing Expansion of PhaseOut DMD, a Phase 2 Clinical Trial of Ezutromid (SMT C1100), Into the...
April 28 2016 - 10:46AM
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 US Food and Drug Administration has cleared the
Company’s investigational new drug (‘IND’) application to expand
the Phase 2 proof of concept clinical trial called PhaseOut DMD to
trial sites in the US. PhaseOut DMD will evaluate the Company’s
lead utrophin modulator, ezutromid (formerly known as SMT C1100),
in patients with DMD at sites in the UK and the US.
In contrast to many current therapeutic
approaches to DMD, utrophin modulation has the potential to treat
all boys and young men with DMD, regardless of their underlying
dystrophin gene mutation.
“The IND clearance for PhaseOut DMD paves the
way to expand PhaseOut DMD into the US and will provide access to a
wider network of leading physicians in DMD as we seek to improve
the lives of patients and families living with this devastating
disease,” said Ralf Rosskamp, MD, Chief Medical Officer of
Summit. “PhaseOut DMD aims to show the potential benefits
of ezutromid as a disease modifying approach for DMD for the first
time in patients, and this approach could ultimately benefit the
entire DMD patient population.”
Summit expects to begin enrolling patients into
US sites in the third quarter of 2016.
About PhaseOut DMDPhaseOut DMD
aims to provide proof of concept for ezutromid (SMT C1100) 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.
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.
*Ezutromid is the international nonproprietary
name (‘INN’) recommended by the World Health Organization for SMT
C1100. INNs, also known as generic names, are used globally to
identify pharmaceutical substances.
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) |
Tel:
+44 (0)1235 443 951 +1 617 225 4455 |
|
|
Cairn
Financial Advisers LLP(Nominated Adviser)Liam Murray /
Tony Rawlinson |
Tel:
+44 (0)20 7148 7900 |
|
|
N+1
Singer (Broker)Aubrey Powell / Jen Boorer |
Tel:
+44 (0)20 7496 3000 |
|
|
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 |
|
|
MacDougall Biomedical Communications(US media
contact)Chris Erdman |
Tel: +1 781
235 3060cerdman@macbiocom.com |
|
|
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, 2015. 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-
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Summit Therapeutics (NASDAQ:SMMT)
Historical Stock Chart
From Sep 2023 to Sep 2024