Summit Therapeutics plc Summit Enrolls Patients In The Us Into Phaseout Dmd, A Phase 2 Clinical Trial Of Ezutromid
November 16 2016 - 7:00AM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
("Summit" or "the Company")
SUMMIT ENROLS PATIENTS IN THE UNITED STATES INTO PhaseOut DMD, A PHASE 2
CLINICAL TRIAL OF EZUTROMID IN PATIENTS WITH DMD
Oxford, UK, 16 November 2016 - 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 that it has enrolled its first
patients at trial sites in the US into PhaseOut DMD, a Phase 2 proof of
concept clinical trial of ezutromid in patients with DMD. Ezutromid
dosing is expected to follow within a screening period of up to 28 days.
Enrolment and dosing of patients into PhaseOut DMD in the UK is ongoing.
Ezutromid is a utrophin modulator and represents a potential disease
modifying treatment for all patients with DMD.
"Ezutromid has shown great promise in preclinical testing as a universal
treatment that has the potential to slow or stop disease progression in
all patients with DMD, regardless of their underlying dystrophin gene
mutation," said John Jefferies, MD, of Cincinnati Children's Hospital
Medical Center, and the US coordinating investigator in PhaseOut DMD.
"We are excited to participate in PhaseOut DMD and contribute to the
clinical development of this utrophin modulator."
Ralf Rosskamp, MD, Chief Medical Officer of Summit added, "Our PhaseOut
DMD clinical trial is an important component of bringing ezutromid to
patients and families who are in urgent need of a disease modifying
therapy, and we are making progress with patient enrolment in this
clinical trial, with enrolment ongoing in the UK and now in the US."
This announcement contains inside information for the purposes of
Article 7 of EU Regulation 596/2014 (MAR).
About PhaseOut DMD
PhaseOut DMD aims to provide proof of concept for ezutromid 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. Each patient will receive
two biopsies, one at baseline and the second either at 24 or 48 weeks.
Data from the initial group of 24-week biopsies are expected Q2/Q3 2017.
Further information is available at:
https://clinicaltrials.gov/ct2/show/NCT02858362 and
www.utrophintrials.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) Tel: +44 (0)1235 443 951
Erik Ostrowski / Michelle Avery (US office) +1 617 225 4455
Cairn Financial Advisers LLP
(Nominated Adviser) Tel: +44 (0)20 7213 0880
Liam Murray / Tony Rawlinson
N+1 Singer
(Broker) Tel: +44 (0)20 7496 3000
Aubrey Powell / Jen Boorer
MacDougall Biomedical Communications
(US media contact) Tel: +1 781 235 3060
Chris Erdman / Karen Sharma cerdman@macbiocom.com
ksharma@macbiocom.com
Consilium Strategic Communications Tel: +44 (0)20 3709 5700
(Financial public relations, UK) summit@consilium-comms.com
Mary-Jane Elliott / Sue Stuart /
Jessica Hodgson / Lindsey Neville
Forward-looking Statements
Any 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-
This announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the information
contained therein.
Source: Summit Therapeutics plc via Globenewswire
http://www.summitplc.com/
(END) Dow Jones Newswires
November 16, 2016 07:00 ET (12:00 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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