Results of Clinical Trial

RNS Number:0945Q
Alizyme PLC
24 September 2003


Meetings today:

Alizyme will be holding an analyst meeting at 10.00 am at the offices of
Buchanan Communications, 107 Cheapside, London EC2V. If you would like to attend
please contact Lisa Baderoon, Rebecca Skye Dietrich or Charlie Forsyth on 020
7466 5000.

Please note, there will not be any other formal group meetings but the Company
will be available for telephone interviews throughout the day. Please contact
Lisa Baderoon, Rebecca Skye Dietrich or Charlie Forsyth on 020 7466 5000 if you
would like to speak to the Company.




Immediate Release                                             24 September 2003


       ALIZYME ANNOUNCES SUCCESSFUL PRELIMINARY RESULTS OF ITS PHASE IIb

               CLINICAL TRIAL OF RENZAPRIDE IN MIXED-SYMPTOM IBS

           AND AN UPDATE OF THE RENZAPRIDE IBS DEVELOPMENT PROGRAMME

Cambridge UK, 24 September 2003: Alizyme plc (LSE:AZM) announces the successful
preliminary results from its Phase IIb clinical trial of renzapride in patients
with mixed-symptom irritable bowel syndrome (m-IBS) and an update of this
programme.


Clinical Trial Highlights:


* First successful demonstration of efficacy and safety in the m-IBS
  patient population


* Increased response rate over placebo for satisfactory relief of m-IBS
  symptoms


* Allows for preparation for Phase III clinical development


* Results suitable for initiating dialogue with regulatory agencies in
  preparation for Phase III and progressing 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) against placebo, administered once daily for
eight weeks following a two-week run-in period. The trial, in 168 evaluable
patients with m-IBS, was carried out in hospitals in the UK, in four other
European countries and in twenty three general practice surgeries in the UK.
This was the first trial of a drug for IBS carried out specifically in the m-IBS
patient population and was designed to test hypotheses about the effects of
renzapride and about trial design in this patient population.


At the optimum dose of 2mg per day, up to 14% more patients at any one time
(average 6% over the treatment period), were classified as responders
(satisfactory relief of IBS on more than 50% of days during treatment) compared
to placebo. This proportion of responders over placebo was increased to 18%
(average 8%), when only the data from female patients were evaluated. The
proportion of female patients in this dose group classified as responders, in
terms of relief of abdominal pain and discomfort and of relief of bowel
dysfunction, also showed an increase over placebo.


The daily responder rate during the two-week run-in period was approximately 30%
for all groups. This was increased to up to 57% in the 2mg treatment group,
compared to up to 43% in placebo.


Renzapride was well tolerated at all doses and had no clinically relevant
effects on ECG or laboratory variables. Furthermore, there were no safety issues
to preclude further development.


Programme Update:


* Improved response rate by up to a further 4.6% over placebo for female
  patients in the constipation-predominant IBS (c-IBS) Phase IIb clinical trial,
  previously announced in April 2003.


* New manufacturing patent application filed for renzapride - patent
  protection could be extended until 2023


Additional analysis of the preliminary results of the c-IBS Phase IIb clinical
trial, reported earlier this year, indicates that the improved response rate
over placebo is enhanced by analysing the data from female patients only,
increasing the average weekly response rate by up to 4.6% from 7.7% to 12.3%.
This reinforces the conclusions from that trial of the potential of renzapride
in the treatment of c-IBS patients.

As a result of manufacturing development activities in this programme, Alizyme
has filed a new patent application claiming various features of the manufacture
of renzapride on a commercial scale. If granted this patent could provide
protection for renzapride manufactured by this commercial process until 2023.

Alizyme is also conducting a pharmacokinetic/pharmacodynamic clinical trial at
Mayo Clinic in the USA to establish the relationship between the levels of drug
absorbed and gastrointestinal motility in up to 48 c-IBS patients. This trial is
expected to report by the end of the year.


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

"We are very pleased that this trial has confirmed the unique and distinct
nature of this population of IBS patients and shown an effect of renzapride on
the symptoms of IBS, together with a safety profile suitable for further
development. These results confirm the hypothesis that m-IBS patients differ
substantially from c-IBS patients and indicate that this promising effect of
renzapride, coupled to its safety profile, provides the potential for it to be
first line therapy in this important group of patients.

The results of this trial, together with those from our c-IBS study reported
earlier this year, allow us to prepare for dialogue with regulatory authorities
in preparation for Phase III development. In addition, these data confirm the
wider potential for this drug in the management of IBS, enhancing our
negotiating position with potential licensing partners, by offering the
opportunity for a unique position in the treatment of 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


Editor's 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 (completed 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 (approximately 70% women, 30% men);
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 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.






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