Re Renzapride Clinical Trial
19 Março 2003 - 4:00AM
UK Regulatory
RNS Number:9026I
Alizyme PLC
19 March 2003
Immediate Release 19 March 2003
ALIZYME COMPLETES PATIENT RECRUITMENT IN PHASE IIb CLINICAL TRIAL
OF RENZAPRIDE IN IRRITABLE BOWEL SYNDROME
Cambridge UK, 19 March 2003: Alizyme plc (LSE:AZM) is pleased to announce the
completion of patient recruitment in its Phase IIb clinical trial of renzapride
in patients with alternating or mixed-symptom irritable bowel syndrome (m-IBS).
The multi-centre trial, in which over 170 patients have been enrolled, is being
conducted in 5 European countries, including the UK. It is a randomised,
double-blind, parallel group study and is measuring the effectiveness of
renzapride in providing symptom relief in these patients, comparing three doses
of renzapride with placebo over an 8 week treatment period.
Preliminary results from this trial are anticipated to be announced in October
2003. Positive results would provide valuable information to assist in the
design of the Phase III clinical programme. The patients recruited will add
considerably to the clinical safety database of renzapride in preparation for
the eventual submission to regulatory authorities for marketing approval.
Positive results would also facilitate Alizyme's commercial exploitation of
renzapride through the securing of out-licensing partners.
Renzapride is also being studied in a separate Phase IIb clinical trial, in a
total of 514 patients with constipation-predominant IBS (c-IBS) in the UK
primary care setting, from which preliminary results are expected in May 2003.
In addition, renzapride is being studied in a pharmacokinetic/pharmacodynamic
study at Mayo Clinic in the USA, involving up to 48 c-IBS patients, to determine
the relationship between the effects of different doses on gastrointestinal
motility and levels of drug absorbed. This study is expected to report in Q4,
2003.
IBS is a common gastrointestinal disorder affecting up to 20% of the Western
population. Renzapride exhibits a unique dual pharmacological profile which may
permit its potential use in the treatment of both constipation-predominant and
mixed-symptom IBS.
Dr. Richard Palmer (Chief Executive Officer) commented:
"The completion of recruitment in this Phase IIb study is another milestone for
Alizyme and potentially for IBS patients suffering from mixed symptoms, for
which there is currently no effective treatment. Successful results in this
indication would allow Alizyme to exploit a larger commercial opportunity for
renzapride, as mixed symptom patients comprise up to 45% of the total IBS
market."
For further information, please contact:
Dr Richard Palmer, Chief Executive Officer
Mr Tim McCarthy, Finance Director
ALIZYME plc Tel No: + 44 (0)1223 896000
Lisa Baderoon/ Tim Anderson
BUCHANAN COMMUNICATIONS Tel No: + 44 (0)20 7466 5000
Further information on Alizyme can be found on the Company's website:
www.alizyme.com
Editors Note:
Alizyme plc
Alizyme is a biopharmaceutical company, based in Cambridge, UK, targeting the
treatment and management of gastrointestinal disorders, obesity and diabetes. It
has a portfolio of products under development, which in addition to renzapride
includes COLAL-PRED(TM) (Phase III for the management of ulcerative colitis),
ATL-962 (Phase IIb for obesity) and ATL-104 (completed Phase I for mucositis).
At the appropriate time Alizyme intends to license products to established
pharmaceutical companies, who would complete development, gain marketing
approval and commercialise the products.
Irritable Bowel Syndrome
IBS is a common gastrointestinal disorder. Important symptoms include abdominal
pain and discomfort, altered bowel habit and feeling of bloating. In IBS, the
normal contractile patterns of the gut are disrupted resulting in irregular or
spasmodic bowel movements. Sufferers may experience either a constipation or a
diarrhoea predominant form of IBS or, in 'mixed symptom' IBS, alternate between
these conditions. It has been estimated that up to 20% of adults in developed
countries are affected to some degree by IBS; of these between 20-30% consult a
doctor. Current treatments, which are aimed at providing symptomatic relief to
IBS sufferers, include laxatives, anti-diarrhoeal and antispasmodic products.
These products, however, have limited efficacy for the condition and it is
generally accepted that the market is poorly served. In July 2002, Novartis
received marketing approval from the Food and Drug Administration in USA for
their product Zelnorm(R), a 5-HT4 receptor agonist, for the treatment of
non-diarrhoea IBS in women. Zelnorm(R), also known internationally as Zelmac(R),
is also approved in more than 30 countries including Australia, Switzerland,
Canada and Brazil. It has not yet been approved in Europe.
Renzapride
Alizyme is currently developing renzapride for the treatment of IBS. Renzapride
is a novel benzamide derivative and a potent full 5-HT4 receptor agonist; it is
also an antagonist at 5-HT3 receptors. These 5-HT receptors are believed to play
a key role in controlling gastrointestinal motility and sensitivity. The
distinct, dual pharmacological profile of renzapride differentiates it from
other drugs currently in development for the treatment of IBS. Renzapride was
discovered by Beecham Research Laboratories and investigated by them initially
as a gastrointestinal prokinetic agent for the treatment of gastroesophageal
reflux disease. Following a collaborative agreement with SmithKline Beecham
(SKB), Alizyme obtained full ownership of the rights to renzapride prior to the
SKB merger with Glaxo Wellcome.
The identification of compounds for successful research, their progress through
development and the obtaining of regulatory approvals or authorisations before
marketing, manufacture and/or distribution of products is not certain or a
formality.
This information is provided by RNS
The company news service from the London Stock Exchange
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