Summit Therapeutics plc Summit Joins Ctap In Effort To Enhance Development Of Utrophin Modulators And Other Treatments For Dmd
25 September 2017 - 9:00PM
UK Regulatory
TIDMSUMM
Summit Therapeutics plc
('Summit', or 'the Company')
SUMMIT JOINS cTAP IN COLLABORATIVE EFFORT TO ENHANCE THE DEVELOPMENT OF
UTROPHIN MODULATORS AND OTHER TREATMENTS FOR DUCHENNE MUSCULAR DYSTROPHY
Oxford, UK, 25 September 2017 - 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 joined the Collaborative
Trajectory Analysis Project ('cTAP') to support cTAP's mission of
accelerating the development of drugs to treat DMD through a coalition
of Duchenne clinical experts, patient advocates and biopharmaceutical
companies.
"In the Duchenne field, there is a strong community amongst the families,
patient organisations, caregivers and industry that comes together to
improve the lives of patients living with this disease, where time is of
the essence," said Dr David Roblin, President of R&D of Summit. "cTAP is
leveraging the natural history and clinical data collected within this
community to create more predictive models of disease progression with
the aim of enabling companies to interpret data and improve the design
of clinical trials in DMD. We believe this could potentially benefit the
development of our utrophin modulators for the treatment of all patients
with DMD. In addition, we have the opportunity to contribute our own
data to aid others as we all seek to improve the lives of DMD patients
and their families."
Debra Miller, founder and CEO of CureDuchenne and initial funder of cTAP
commented: "cTAP was started with the single mission of helping
biopharmaceutical companies to bring treatments to our children living
with DMD as quickly as we possibly can. This mission is only made
possible through a collaboration of clinicians, patient advocates and
the biopharma industry, and we welcome Summit in this effort."
Professor Eugenio Mercuri, Neurology and Pediatrics, Università
Cattolica del Sacro Cuore, Rome, Italy, added: "cTAP's initiative has
brought together a wealth of data from clinicians and biopharmaceutical
companies. This resource could assist Summit in developing its
potentially universal treatments for patients with DMD, and in turn,
Summit's data could contribute to the wider cTAP collaboration."
Summit's lead utrophin modulator candidate for the treatment of DMD,
ezutromid, is currently in a Phase 2 clinical trial called PhaseOut DMD.
The trial aims to establish proof of concept of ezutromid through a
range of muscle structure, muscle health and functional endpoints. The
trial uses quantitative magnetic resonance to measure fat fraction in
leg muscles as its primary endpoint. This technique is emerging as a
tool to measure muscle health since the fat fraction increases as the
disease progresses over time. In addition, the Company plans to measure
utrophin and a biomarker of muscle regeneration (developmental myosin)
from muscle biopsies provided at baseline and again after either 24 or
48 weeks of treatment. These measurements could provide early evidence
of ezutromid's activity. Finally, PhaseOut DMD assesses functional
measures, such as the six minute walk distance and North Star Ambulatory
Assessment, as exploratory endpoints. Summit expects to report 24-week
data in the first quarter of 2018, and data from the full 48-week trial
are expected in the third quarter of 2018.
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 had
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 cTAP
Driven by a shared mission to overcome the challenges of developing
drugs for diseases characterized by heterogeneous progression, cTAP
brings advanced data science to a dynamic alliance of all stakeholders
in the ecosystem - a first in Duchenne. The Collaborative Trajectory
Analysis Project, or cTAP, is enabling clinical experts to solve the
most critical problems in drug development for Duchenne muscular
dystrophy. The first community-wide coalition in Duchenne, cTAP has
forged an alliance between clinical experts, drug companies developing
therapies, patient advocacy organizations and collaborating registries
and clinical centers across Europe and the US. cTAP brings advanced data
science to the fight against Duchenne through a partnership with
outcomes research experts at Analysis Group Inc.
(http://www.analysisgroup.com/). cTAP is curating and growing what is
already the largest natural history database of patient data in
Duchenne. This rich resource enables cTAP to develop solutions with the
urgency necessary to enhance clinical trial design and analysis,
near-term. http://ctap-duchenne.org
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
cTAP
Susan J. Ward, PhD 617-448-2617
susanjward@ctap-duchenne.org
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 / Lauren Kettle
MacDougall Biomedical Communications
(US media contact) Tel: +1 781 235 3060
Karen Sharma 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,
the potential benefits of Summit's collaborative work with cTAP 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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Source: Summit Therapeutics plc via Globenewswire
http://www.summitplc.com/
(END) Dow Jones Newswires
September 25, 2017 07:00 ET (11:00 GMT)
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