Research Update
30 March 2010 - 5:00PM
UK Regulatory
TIDMSUMM
Summit Corporation plc
("Summit" or "the Company")
RESEARCH UPDATE:
* Exciting New Progress in Key R&D Programmes
Oxford, UK, 30 March 2010,Summit (AIM: SUMM), a UK drug discovery Company with
partner funded programmes and its innovative SeglinTM (second generation
iminosugar) technology platform for the discovery of new medicines, is today
pleased to report exciting new progress is being made across its key research
and development programmes.
Partner Funded Programmes
* Progression of DMD programme by BioMarin Pharmaceuticals into a Phase I
clinical trial with results expected in Q3 2010
* SMT 19969 selected as lead compound having displayed high levels of activity
againstC. difficile pathogen in Wellcome Trust funded programme
SeglinTM Technology: Identifying medicines from new chemistry space
* Advances in development of SeglinTM technology platform with active
compounds identified against a range of major disease areas
* Positive results generated in diabetes programme with lead candidate SMT
14224 demonstrating proof of concept in acute and chronicin vivo models
* Major breakthrough in hepatitis C programme following identification of hits
against previously intractable NS3 helicase protein target
Steven Lee, PhD, Chief Executive Officer of Summit commented:
"Following our trading update released on 24 February that outlined our two
years of funding, the progress announced today provides a solid base to deliver
value growth for investors within this timeframe."
"The entry of BMN-195 for DMD into clinical trials brings closer the potential
of a vital treatment option for patients as well as being an important milestone
for the Company. In addition, the SeglinTM technology platform is delivering
significant scientific results, including hits against NS3 helicase, a validated
target that has remained intractable despite major efforts by industry over the
last decade. This exemplifies the potential of SeglinsTM as a source of new
medicines."
"I look forward to our assets achieving key value junctures over the next 12
months."
PARTNER FUNDED PROGRAMMES
Duchenne Muscular Dystrophy programme
Summit's programme targeting the fatal genetic disorder Duchenne Muscular
Dystrophy ('DMD') could provide major benefits to patients. The programme was
exclusively licensed to BioMarin Pharmaceutical Inc. ('BioMarin') in July 2008
and Summit is eligible to receive significant development and regulatory
milestone payments and tiered royalties on net sales rising to a low teen
percentage. In January 2010, BioMarin announced it had initiated a Phase I
clinical trial of the compound, SMT C1100, which is today re-designated BMN-195.
BioMarin indicated that top-line results are anticipated by Q3 2010, and if
successful, a Phase II patient trial is scheduled for Q12011 which would trigger
a $3 million milestone payment to Summit. Summit incurs no further costs for
the DMD programme.
DMD is caused by lack of a protein called dystrophin that is essential in
maintaining the correct function of all muscles in the human body. BMN-195 was
discovered by scientists at Summit and is an oral small molecule upregulator of
utrophin, a protein similar to dystrophin. Summit's preclinical studies have
shown pharmacological upregulation of utrophin has the potential to compensate
for the missing dystrophin. Significantly, this potential first-in-class
disease modifying therapy could treat the entire spectrum of DMD patients.
C. difficile programme
Summit is developing a new class of antibiotics targetingC. difficile, a life
threatening pathogen for which current therapy options are limited. In 2008 in
the UK, C. difficile was responsible for over three times more deaths than the
MRSA superbug, while the annual cost of care in the US is estimated at $1.1
billion and rising.
Summit has identified a novel class of small molecules with an attractive
activity profile. The lead compound in the series, SMT 19969:
* Selectively killsC. difficile, a key property for any new drug treating this
pathogen;
* Displays high levels of activity against all clinically relevantC. difficile
strains including the endemic, hyper-virulent 027 strain that represents a
major healthcare threat due to higher mortality rates.
The award in December 2009 of a GBP2.2 million grant by the Wellcome Trust is
expected to fund the programme through until the start of human clinical trials.
SMT 19969 has advanced into proof of concept studies in the gold standardin vivo
model. In addition, in depth bacterial resistance and mechanism of action
studies are on-going, while an extensive back-up chemistry programme has
commenced.
The results from these non-clinical efficacy studies are expected in the second
half of this year.
SEGLINTM TECHNOLOGY: Identifying medicines from new chemistry space
Summit's second generation lead iminosugar (SeglinTM) technology is using new
chemistry to access biological targets that have not been exploited by
conventional drug discovery approaches.
Summit has validated the platform by identifying a number of orally available
advanced Seglin compounds in a range of therapy areas:
* SMT 14224 for type II diabetes
* SMT 14400 for inflammation and cancer
* SMT 15000 as a biodefence countermeasure
In addition, Summit has generated Seglin hits against viral infections,
including hepatitis C, and a range of other diseases.
Collectively, these data exemplify the potential power of the platform in being
able to identify new drugs in a wide range of major therapy areas and this
innovative technology is generating increasing interest from the pharmaceutical
and biotechnology industry. Summit aims to exploit the technology's potential
by developing programmes in its current focus therapy areas of type II diabetes
and infectious diseases and establishing strategic alliances in other diseases.
Diabetes (SMT 14224)
Summit's type II diabetes programme focuses on its lead compound, SMT 14224, as
a potential treatment for this metabolic disorder that affects over 18 million
patients in the US alone, and has a global market worth in excess of $30 billion
per annum.
SMT 14224 has demonstrated proof of concept in well validated acute and
chronicin vivo models. Importantly, the positive results from this Seglin
indicate it may operate via a new mechanism of action. In summary, the results
show SMT 14224:
* Increases insulin levelsin vivo models via a glucose dependent mechanism. In
vitro studies provide further support by showing the compound increases
insulin release to levels associated with a market leading GLP-1 agonist;
* Reduces HbA1c (blood glucose) levels in a chronicin vivo study, an important
measurement of disease control in patients;
* Lowers serum glucose levels, a measure of insulin response and sensitivity,
after an oral glucose tolerance test ('OGTT')
* Lowers triglyceride levels with no weight gain being observed in a chronicin
vivo study.
Furthermore, a set of additional compounds have been identified fromin vitro
screening and are now undergoing optimisation work.
These data have generated interest from potential pharmaceutical and
biotechnology partners and Summit is undertaking additional studies to add
further value to this programme. These studies will seek to reinforce data
already generated to confirm the potential unique clinical position of SMT
14224 and also provide further insight into the compounds underlying mechanism
of action. Results are expected in the second half of 2010.
Infectious diseases: Hepatitis C
Summit is making good progress with its research activities in its second
therapy focus area, infectious diseases, and specifically viral diseases.
As part of Summit's Hepatitis C ('HCV') programme, the Company is using its
SeglinTM technology against a set of HCV targets including the NS3 helicase
protein, an enzyme that unwinds the double-stranded RNA complex allowing the
virus to replicate. HCV Helicase is a validated target that has so far proved
intractable, despite the major efforts made over the last ten years by the
pharmaceutical industry. From preliminary studies, Summit has identified a
number of active Seglins against this enzyme. This represents a major
breakthrough towards finding new drugs against HCV, and importantly, exemplifies
the wider potential of Seglins to access intractable targets. Further results
from on-going studies are expected in the second half of 2010.
- END -
For more information, please contact:
Summit
Steven Lee, PhD
Richard Pye, PhD Tel: +44 (0)1235 443939
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@peckwaterpr.co.uk
<mailto:tarquin.edwards@peckwaterpr.co
.uk>
About Summit
Summit is an Oxford, UK based drug discovery company with a portfolio of partner
funded drug programmes and an innovative technology platform called SeglinsTM
for the discovery of new medicines.
Summit's partnered drug programmes require no further investment from the
Company but have contractual, success-based milestones potentially worth in
excess of $160 million and sales royalties rising to a low teen percentage.
Partners include leading orphan drug specialist BioMarin Pharmaceuticals
(Duchenne Muscular Dystrophy programme) and the Wellcome Trust (C. difficile
programme).
SeglinTM 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 type
II diabetes and infectious diseases and the Company will further exploit the
technology's wider potential through strategic alliances.
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
<http://www.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.
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