Research Update: Positive results in C. difficile programme
(Thomson Reuters ONE) -
Summit Corporation plc
("Summit plc" or "the Company")
POSITIVE RESULTS REPORTED IN CLOSTRIDIUM DIFFICILE PROGRAMME
* Proof of concept established in non-clinical efficacy studies
* SMT 19969 shown to be superior to existing treatment options
Oxford, UK, 12 October 2010, Summit (AIM: SUMM), a UK drug discovery Company,
today announces positive results from its Wellcome Trust funded proprietary
programme to develop a new, differentiated class of antibiotics targeting the
'superbug' Clostridium difficile ('C. difficile').
C. difficile is a life-threatening bacterium for which the only current therapy
options are broad spectrum antibiotics that are associated with high rates of
recurrent C. difficile infection ('CDI'). In 2009 in the UK, CDI was
responsible for approximately five times more deaths than MRSA while the
combined annual cost of care in Europe and North America is estimated at $7.0
billion.
Commenting on the results, Steven Lee, Chief Executive Officer at Summit said:
"The positive results reported demonstrate the tremendous progress that our C.
difficile programme has made, and with the financial support of the Wellcome
Trust, Summit looks forward to continuing to advance SMT 19969 through to human
clinical trials."
Results of Non-clinical Efficacy Studies
SMT 19969 meets the target profile for a new C. difficile antibiotic, namely:
Potency against the bacterium; a very narrow spectrum of activity to prevent
recurrence of CDI; and an excellent resistance profile. The positive results
from these non-clinical efficacy studies show SMT 19969 has the potential to
become a differentiated front-line therapy, with superiority over existing
treatment options:
* Provides total protection from both initial infection and recurrence in the
in vivo gold standard model of CDI
* Potent activity against a comprehensive panel of C. difficile clinical
isolates including the endemic, hyper-virulent 027/BI/NAP1 strain
* A significantly narrower spectrum of activity than any other C. difficile
antibiotic
* No anti-bacterial effect on, or damage to gut flora
* Unprecedented, low levels of resistance development
* Targeted to the site of infection and shown to have a good safety profile
In addition, a strong backup programme has been established that has identified
compounds with comparable profile to SMT 19969.
Summit has worked closely in the development of SMT 19969 with a number of key
opinion leaders in the field. Professor Mark Wilcox, Consultant and Clinical
Director of Microbiology & Pathology at the Leeds Teaching Hospitals NHS Trust,
and the Health Protection Agency's leader on C. difficile infection in England
commented: "There is a paucity of treatment options available for C. difficile
infection (CDI). A measure of an antibiotic's success in treating CDI may
relate to minimising its detrimental effects on gut flora. In vitro, in vivo
and human gut model data for SMT 19969 show evidence of efficacy in this
difficult treatment area, whilst minimising its effects on gut flora."
Infectious disease expert William Weiss, Director of Pre-Clinical Services at
the University of North Texas Health Science Centre in Fort Worth, who performed
the in vivo studies, added: "These results are very promising and show that SMT
19969 exhibits a clearly defined antibiotic effect and is superior to currently
approved treatment options. If these results are replicated in man, SMT 19969
has the potential to become a new and highly effective antibiotic for the
treatment of C. difficile infections."
Summit's C. difficile programme, including SMT 19969, is being supported by a
prestigious grant from the Wellcome Trust that will fund the programme through
to the start of human clinical trials. Dr Rick Davis, Business Development
Manager at the Wellcome Trust said: "C. difficile infection poses a serious
healthcare challenge and there is a pressing need to develop new antibiotic
treatments. The Wellcome Trust is pleased with the excellent progress Summit
has made towards development of a potential new treatment."
- END -
For more information, please contact:
Summit
Steven Lee, PhD
Richard Pye, PhD Tel: +44 (0)1235 443 951
Singer Capital Markets (Nominated Adviser)
Shaun Dobson / Claes Spång Tel: +44 (0)20 3205 7500
Peckwater PR
Tarquin Edwards Tel: +44 (0)7879 458 364
tarquin.edwards(at)peckwaterpr.co.uk
Notes to Editors
About C. difficile
Clostridium difficile infection ('CDI') has become a significant medical problem
in hospitals, long-term care facilities, and in the community. It is a serious
illness caused by infection of the inner lining of the colon by C. difficile
bacteria, which produces toxins that cause inflammation of the colon, severe
diarrhoea and, in the most serious cases, death. Patients typically develop CDI
from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal
(gut) flora, and thus allowing C. difficile bacteria to flourish.
Current therapeutic options for CDI include the off-label use of metronidazole
and oral vancomycin, the only FDA-approved treatment. However, approximately
20% to 30% of CDI patients who initially respond to these treatments experience
a clinical recurrence following cessation of antibiotic administration.
Primary risk factors for CDI include broad-spectrum antibiotic use (eg
cephalosporins and fluoroquinolones that effect a wide range of bacteria),
advanced age (over 65) and exposure to emerging hyper-virulent strains
(027/BI/NAP1) of C. difficile. Increasing incidence, higher treatment failures
and recurrence with current therapies have resulted in greater awareness and
concern of CDI among medical professionals and public health officials.
About the Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving
extraordinary improvements in human and animal health. It supports the brightest
minds in biomedical research and the medical humanities. The Trust's breadth of
support includes public engagement, education and the application of research to
improve health. It is independent of both political and commercial interests.
www.wellcome.ac.uk
About Summit plc
Summit is an Oxford, UK based drug discovery company with an innovative
technology platform called Seglins(TM) for the discovery of new medicines, a
portfolio of partner funded drug programme assets and a commercial strategy of
signing multiple early-stage deals
Seglin(TM) technology is using new chemistry to access biological drug targets
that cannot be exploited by conventional drug discovery approaches. Summit's
internal research is currently focussed in the high-value therapy areas of
metabolic and infectious diseases and the Company will further exploit the
technology's wider potential through strategic alliances. Summit's programme
portfolio consists of a number of drug programmes that require no further
investment from the Company but have the potential to deliver future upside for
the business.
Summit's commercial strategy focuses on signing multiple early-stage drug
programme and technology platform deals that generate upfront cash, remove
development costs from the Company, and retain valuable upside potential.
Summit is listed on the AIM market of the London Stock Exchange and trades under
the ticker symbol SUMM. Further information is available atwww.summitplc.com.
Forward Looking Statements
This document contains "forward-looking statements" within the meaning of the
U.S. Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as "anticipates", "intends", "plans",
"seeks", "believes", "estimates", "expects" and similar references to future
periods, or by the inclusion of forecasts or projections.
Forward-looking statements are based on the Company's current expectations and
assumptions regarding our business, the economy and other future conditions.
Because forward-looking statements relate to the future, by their nature, they
are subject to inherent uncertainties, risks and changes in circumstances that
are difficult to predict. The Company's actual results may differ materially
from those contemplated by the forward-looking statements. The Company cautions
you therefore that you should not rely on any of these forward-looking
statements as statements of historical fact or as guarantees or assurances of
future performance. Important factors that could cause actual results to differ
materially from those in the forward-looking statements and regional, national,
global political, economic, business, competitive, market and regulatory
conditions.
[HUG#1450355]
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Source: Summit Corporation PLC via Thomson Reuters ONE
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Datum: 12.10.2010 - 08:00 Uhr
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