Summit Joins cTAP in Collaborative Effort to Enhance the Development of Utrophin Modulators and Other Treatments for Duchenne...
September 25 2017 - 6:00AM
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 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 cTAPDriven 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 |
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Glyn
Edwards / Richard Pye (UK office)Erik Ostrowski /
Michelle Avery (US office) |
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Tel:
+44 (0)1235 443 951 +1 617 225 4455 |
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cTAPSusan J. Ward, PhD |
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617-448-2617susanjward@ctap-duchenne.org |
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Cairn Financial Advisers LLP(Nominated
Adviser)Liam Murray / Tony Rawlinson |
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Tel:
+44 (0)20 7213 0880 |
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N+1 Singer (Broker)Aubrey Powell / Lauren
Kettle |
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Tel:
+44 (0)20 7496 3000 |
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MacDougall Biomedical Communications(US media
contact)Karen Sharma |
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Tel:
+1 781 235 3060ksharma@macbiocom.com |
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Consilium Strategic Communications (Financial
public relations, UK)Mary-Jane Elliott / Sue Stuart / Jessica
Hodgson / Lindsey Neville |
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Tel: +44
(0)20 3709 5700 summit@consilium-comms.com |
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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, 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.
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