RNS Number:3147K
Alizyme PLC
24 April 2003

THERE WILL BE AN ANALYST BRIEFING AT 9.30AM AND A PRESS BRIEFING AT 11.00AM,
TODAY,  AT THE OFFICES OF BUCHANAN COMMUNICATIONS, 107 CHEAPSIDE, LONDON EC2V
6DN.




For Immediate Release                                              24 April 2003





         ALIZYME ANNOUNCES PRELIMINARY RESULTS OF SUCCESSFUL PHASE IIb
            CLINICAL TRIAL OF RENZAPRIDE IN IRRITABLE BOWEL SYNDROME



Cambridge UK, 24 April 2003: Alizyme plc (LSE:AZM) announces preliminary results
from its successful Phase IIb clinical trial of renzapride in patients with
constipation-predominant irritable bowel syndrome (c-IBS).



Highlights:



*         Successful demonstration of efficacy and safety


*         Efficacy profile across a range of c-IBS symptoms quantitatively and
          qualitatively similar to that of tegaserod (Novartis' Zelmac/Zelnorm), 
          the only drug currently approved for these patients


*         Allows for preparation for Phase III clinical development


*         Results suitable for initiating discussions with potential licensing
          partners


This trial was a randomised, double-blind, placebo-controlled, parallel group,
dose-ranging study, which evaluated the efficacy and safety of three doses of
renzapride (1, 2, and 4 mg/day) and placebo, administered once daily, over a
twelve-week treatment period, following a two-week run-in period. The trial, in
510 evaluable patients with c-IBS, was carried out in eighty general practice
surgeries in the UK.



The data obtained for renzapride across the IBS symptom profile in these
patients was similar to the level of overall benefit reported for Novartis'
tegaserod (Zelmac/Zelnorm) during its Phase III clinical trials, of
approximately 8% improvement over placebo. Zelnorm is approved in the USA and in
more than 30 other countries for the treatment of women with c-IBS. In addition,
the results of the present trial are also consistent with the data from
Alizyme's pilot Phase IIa clinical trial of renzapride in c-IBS patients.



The primary end-point of the trial was the patients' weekly assessment of
adequate relief of abdominal pain and discomfort during weeks 5-12 of treatment.
A patient was classified as a responder if they recorded adequate relief in 75%
of the weeks of treatment. This end-point represented a substantially higher
target than that employed in clinical trials for other products in this
indication.



Renzapride treatment increased the responder rate for adequate relief of
abdominal pain and discomfort by up to 9% over that for patients treated with
placebo. Treatment with renzapride also increased both the frequency of bowel
movements and improved stool consistency. These latter effects were dose-related
and reached statistical significance on frequency of bowel movements at 2 and 4
mg/day, and on stool consistency at 4 mg/day.



Renzapride was well tolerated at all doses and had no clinically relevant
effects on ECG and laboratory variables. Furthermore, there were no safety
issues to preclude further development. The most common adverse events were
diarrhoea (25.2%) and headache (17.8%) at the highest dose, compared to 9.6% and
13.6%, respectively, in the placebo group.



Alizyme is also conducting a 170 patient trial of renzapride in patients with
alternating or mixed-symptom IBS (m-IBS), which has completed patient enrolment
and is expected to report preliminary results in October this year. The m-IBS
patient population is distinct from that of c-IBS, representing approximately
40% of the total IBS population, and is therefore a significant commercial
opportunity. In addition, a pharmacokinetic/ pharmacodynamic clinical trial at
Mayo Clinic in the USA is also ongoing; this trial aims to establish the
relationship between the levels of drug absorbed and gastrointestinal motility
in c-IBS patients.



Dr. Richard Palmer, Chief Executive Officer, commenting on these results said:



"We are very pleased that this trial has shown an effect of renzapride on pain
and bowel motility in these patients, together with a safety profile suitable
for further development of renzapride in this patient population. These results,
combined with the side-effect profile of diarrhoea and headache, are consistent
with its mechanism of action, namely 5-HT4 agonism. The efficacy and safety of
renzapride are similar to that reported for tegaserod  in this patient
population, and are in line with the data obtained in other clinical trials in
IBS patients, and are therefore very encouraging.



The robust design of this Phase IIb trial has established renzapride's clinical
and competitive profile and allows us to prepare for Phase III development,
whilst initiating dialogue with potential licensing partners. We are looking
forward to receiving the results of the m-IBS trial later this year, which, if
successful, would confirm the role of renzapride in the treatment of IBS and its
overall commercial potential."



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
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 (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 tegaserod (Zelnorm), a 5-HT4 receptor partial agonist, for the
treatment of non-diarrhoea IBS in women. Zelnorm, also known internationally as
Zelmac, is also approved in more than 30 countries including Australia,
Switzerland, Canada and Brazil. It has not yet been approved in the European
Union.



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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