Summit Completes Enrolment of PhaseOut DMD, a Phase 2 Clinical Trial of Ezutromid in Patients with DMD
May 15 2017 - 7:00AM
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 completed enrolment in PhaseOut DMD, a
Phase 2 proof of concept clinical trial of the utrophin modulator,
ezutromid, in patients with DMD. PhaseOut DMD aims to provide proof
of concept for ezutromid through measures of a number of endpoints
related to muscle structure, health and function. The Company
believes the trial could provide valuable insight into utrophin
modulation as a potential disease-modifying treatment for all
patients with DMD, regardless of the underlying dystrophin
mutation.
With the dosing of the last patient in the
trial, the Company has triggered a $22 million milestone payment as
part of the Company’s licence and collaboration agreement with
Sarepta Therapeutics, Inc.
“Completing enrolment in PhaseOut DMD is a major
step in the development of ezutromid as we seek to understand if
this utrophin modulator has positive effects on muscle structure
leading to changes in muscle health and function in patients with
DMD,” said Dr David Roblin, Chief Operating Officer and
President of R&D of Summit. “Utrophin modulation has
potential as a universal treatment option for patients with DMD,
and we look forward to the 24-week data readout expected in the
first quarter of 2018.”
PhaseOut DMD is a 48-week open-label trial that
has enrolled 40 patients at sites in the UK and the US. As part of
the trial, each patient undergoes two biopsies, a baseline biopsy
on enrolment and a second either at 24 or 48 weeks. In the first
quarter of 2018, Summit expects to report 24-week biopsy analysis
from approximately 20 patients, as well as 24-week MRI and
functional data from all 40 patients enrolled in the trial.
Top-line data from the complete 48-week trial are expected in the
third quarter of 2018.
Further information about PhaseOut DMD 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 the Licence and Collaboration
Agreement with Sarepta Therapeutics, Inc.In October 2016,
Summit announced a licence and collaboration agreement with
Sarepta. This granted Sarepta exclusive commercial rights to the
Company’s utrophin modulator pipeline, including ezutromid, in
Europe, Turkey and the Commonwealth of Independent States, with an
option over specific countries in Central and South America. Summit
retains commercialisation rights in all other countries, including
the US and Japan. Under the agreement, Summit received an upfront
payment and is eligible to receive development, regulatory and
sales milestones related to its utrophin modulator pipeline,
including ezutromid, as well as royalties on net sales in the
licensed territories. For further details, please refer to earlier
RNS announcements and/or Summit’s filings with the Securities and
Exchange Commission.
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 7213 0880 |
N+1 Singer (Broker)Aubrey Powell / Lauren
Kettle |
|
Tel: +44
(0)20 7496 3000 |
MacDougall
Biomedical Communications(US media contact)Karen
Sharma |
|
Tel: +1
781 235 3060ksharma@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 |
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, Summit’s license and collaboration
agreement with Sarepta and the expected receipt of any milestone
payments under the agreement, 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.
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014 (MAR).
-END-
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