Completion of Clinical Trial

RNS Number:0770U
Alizyme PLC
12 January 2004

FOR IMMEDIATE RELEASE                                            12 January 2004

                 ALIZYME SUCCESSFULLY COMPLETES CLINICAL TRIAL
           FOR RENZAPRIDE IN IRRITABLE BOWEL SYNDROME PATIENTS IN USA

Cambridge UK, 12 January 2004: Alizyme plc (LSE:AZM) announces successful
completion of its pharmacokinetic/pharmacodynamic clinical trial of renzapride
in patients with constipation-predominant irritable bowel syndrome (c-IBS), in
collaboration with Mayo Clinic, under Alizyme's Investigational New Drug (IND)
Application in the USA.

The trial, which was conducted at Mayo Clinic in Rochester, Minnesota, USA, with
Dr Michael Camilleri as the Principal Investigator, was a double-blind,
dose-ranging, placebo-controlled pharmacokinetic and pharmacodynamic study
involving 48 c-IBS patients with normal to slow colonic transit. This study
evaluated the pharmacodynamic effects of 3 doses of renzapride (1mg, 2mg and
4mg, once daily) and placebo on gastric emptying, small bowel transit and
segmental colonic transit times, and their correlation with blood levels of this
drug, from the pharmacokinetic profile, in these patients. Patients received
treatment for between 11 and 14 days and kept a daily diary of bowel function
and the weekly response of overall IBS symptoms.

Renzapride caused substantial, dose-dependent enhancement of colonic motility,
which was statistically and clinically significant at the highest dose. Improved
bowel function scores were statistically significantly associated with
accelerated colonic transit. More patients reported satisfactory relief of IBS
symptoms with renzapride (45% and 40% on 2 and 4mg respectively) than on placebo
(18%). Overall, the effects of renzapride correlated with blood levels of the
drug, which showed linear kinetics. There were no significant adverse clinical,
laboratory or ECG effects observed.


Dr. Richard Palmer (Chief Executive Officer) commented:


"The successful completion of this first trial for renzapride in the USA under
the IND is an important step forward for this product in its development for the
global market. We are delighted to have had the opportunity of working with Dr
Camilleri's group at Mayo Clinic on such an important study. The results from
this small study are very encouraging and extend the results reported last year
from our Phase IIb clinical development programme in Europe and reiterate the
potential of this compound in the management of c-IBS."


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 which in addition to renzapride (completed Phase IIb
clinical programme for irritable bowel syndrome) includes COLAL-PREDTM? (Phase III
approval for the maintenance of remission of ulcerative colitis), ATL-962
(completed Phase IIb trial for obesity) and ATL-104 (Phase IIa approval for
mucositis). At the appropriate time Alizyme intends to license products to
established pharmaceutical companies, which will complete development, gain
marketing approval and commercialise the products.


Irritable Bowel Syndrome

IBS is a common gastrointestinal disorder. Important symptoms include abdominal
pain, discomfort and 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.


Renzapride

Alizyme is currently investigating renzapride for the treatment of IBS.
Renzapride is 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 unique, 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, Alizyme obtained full ownership of
patents relating to renzapride from SmithKline Beecham prior to its merger with
GlaxoWellcome.


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.



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