AGI AGI

 

TIDMAGI 
 
RNS Number : 4278Z 
AGI Therapeutics plc 
22 September 2009 
 

AGI Therapeutics 
 
 
Completed analysis of ARDIS data for Rezular(TM) 
 
 
 
 
Dublin, Ireland, 22 September 2009 - AGI Therapeutics plc ("AGI" or the 
"Company") (AIM, IEX: AGI), a speciality pharmaceutical development company, 
today announced that it has completed the data analysis of ARDIS-1 and-3 , it's 
Phase III clinical studies of Rezular(TM) in diarrhoea-predominant irritable 
bowel syndrome (IBS-D). 
 
 
ARDIS 1 study design: 
ARDIS-1 was a double-blind, placebo-controlled, parallel-groups, dose-response 
study of Rezular in IBS-D patients. A total of 708 patients make up the 
intent-to-treat (ITT) safety population. Patients were treated for 12 weeks 
following a baseline/run-in period of 2 weeks. Measures of efficacy were 
typically reported daily by patients. In addition, there were three physician 
visits during therapy, at weeks 4, 8 and 12. Vital signs and laboratory tests 
were performed at all visits and ECG measurements taken at weeks 4 and 12. In 
addition to placebo (P n=174) there were 3 different doses of Rezular treatment, 
15mg t.i.d. (45mg/day (R 45mg n=179)), 37.5mg t.i.d (112.5mg/day (R 112.5mg 
n=177)) and 75mg t.i.d (225mg/day (R 225mg n=178)). 
 
 
ARDIS 1 efficacy data: 
Based on a comprehensive analysis of the data, including a variety of post-hoc 
analyses, the following are the key conclusions in relation to the efficacy of 
Rezular in IBS-D: 
 
 
1.    Based on the protocol-defined end-points, the analysis has confirmed the 
preliminary findings that Rezular at the medium (R 112.5mg) and high dose (R 
225mg) showed a clear effect to normalise the loose/watery stool pattern of the 
IBS-D patients (measured by improvements in stool form using the BSS scale). 
Furthermore, Rezular improved stool frequency and also showed trends to improve 
urgency and also quality of life (QOL). However this analysis, based on 
historically applied end-points, also indicated that Rezular showed no 
improvement in pain relief or improvement in pain severity compared to placebo, 
in the broad IBS-D population. 
 
 
2.    In April 2009, at the Endpoints and Outcomes Conference held in Milwaukee, 
USA and organised by the ROME Foundation to specifically address issues in IBS, 
the US Food and Drug Administration (FDA) indicated their intent in the future 
to focus primarily on changes from baseline in symptom severity in both pain and 
stool function rather than the historical binary global end-point (e.g. adequate 
relief of IBS symptoms). They also proposed the application of a standardised 
definition of clinical response (possibly a one point change from baseline on 
these symptom scales). 
 
 
3.    AGI has analysed the ARDIS data on the basis of these new metrics. This 
analysis re-confirmed the strong profile of response in stool-related measures, 
e.g. stool form and frequency, and also suggested an improvement in pain 
severity in certain post-hoc analyses and in certain sub-populations 
particularly in those patients with the higher baseline pain severity. 
 
 
4.    Overall, the analysis has confirmed the view of AGI that Rezular offers an 
effective treatment for chronic diarrhea symptoms, particularly in conditions 
associated with altered gut motility such as IBS-D. Furthermore, the analysis 
suggests a possible combined activity on stool function and pain. AGI will seek 
an opportunity to discuss these findings with the FDA in the coming months. 
 
 
ARDIS 1 safety data: Overall Rezular was well tolerated and showed a good safety 
profile. There were no deaths or cardiovascular-related serious adverse events 
(SAE's). The incidence of treatment-emergent SAE's was 1.7% (P), 0.6% (R 45mg), 
2.8% (R 112.5mg) and 0.6% (R 225mg) and discontinuations related to AE's were 9% 
(P), 8%( R 45mg), 12% (112.5mg) and 11% (R 225mg). The most common AE-related 
discontinuation was constipation with rates of 1.7% (P), 1.7% (R 45mg), 1.7%(R 
112.5mg) and 2.8% (R 225mg). Average changes in cardiovascular function (blood 
pressure, heart rate and ECG) from baseline were minimal. 
 
 
ARDIS 3 safety data: 
In addition to the safety profile established in ARDIS-1 over 3 months dosing, a 
long-term, open-label safety study (ARDIS-3) which enrolled 349 patients 
directly from ARDIS-1 has been completed. Based on an analysis of the data from 
ARDIS-1 and a preliminary analysis of ARDIS-3, the safety profile of Rezular in 
ARDIS-3 was similar to that reported for ARDIS-1. In particular there were no 
deaths or cardiac related SAE's. There was no case of ischaemic colitis in 
either ARDIS-1 or ARDIS-3. 
 
 
Overall, the safety data from both ARDIS-1 and ARDIS-3 confirmed the generally 
well tolerated and safe profile of Rezular and also confirms the successful 
disassociation of the previously dominant cardiovascular effects of racemic 
verapamil from the desired intestinal effects provided by Rezular. 
 
 
Commenting on the analysis, Dr John Devane, CEO of AGI Therapeutics, said: 
'Despite the disappointment of not meeting the pre-defined efficacy end-point 
(Adequate Relief) in ARDIS-1, our further data analysis leaves us in no doubt 
that Rezular has demonstrated a profile of desirable efficacy improving 
diarrhea-related symptoms in IBS-D patients. Furthermore, the ability of Rezular 
to improve other symptoms (e.g. pain) in certain circumstances is intriguing and 
merits follow up discussions with the FDA. The safety profile of Rezular and in 
particular the absence of any clinically meaningful cardiovascular activity 
validates the use of Rezular as a unique drug with its own profile of 
therapeutic activity distinct and clearly dissociated from that of racemic 
verapamil'. 
 
 
 
 
Contact Information: 
 
 
+------------------------------------------+------------------------------------+ 
| AGI Therapeutics plc.                    | Tel: +353 1 449 3254               | 
+------------------------------------------+------------------------------------+ 
| David Kelly, Chief Financial Officer     |                                    | 
+------------------------------------------+------------------------------------+ 
|                                          |                                    | 
+------------------------------------------+------------------------------------+ 
| Financial Dynamics - UK                  | Tel: +44 (0) 20 7269 7182          | 
+------------------------------------------+------------------------------------+ 
| Jonathan Birt/John Dineen                |                                    | 
+------------------------------------------+------------------------------------+ 
|                                          |                                    | 
+------------------------------------------+------------------------------------+ 
| Financial Dynamics - Ireland             | Tel: +353 1 663 3607               | 
+------------------------------------------+------------------------------------+ 
| Niamh Lyons                              |                                    | 
+------------------------------------------+------------------------------------+ 
|                                          |                                    | 
+------------------------------------------+------------------------------------+ 
| Piper Jaffray Limited                    | Tel: +44 (0) 20 3142 8700          | 
| Neil Mackison                            |                                    | 
| Will Carnwath                            |                                    | 
+------------------------------------------+------------------------------------+ 
|                                          |                                    | 
+------------------------------------------+------------------------------------+ 
| Davy                                     | Tel: +353 1 614 8761               | 
| John Frain                               |                                    | 
+------------------------------------------+------------------------------------+ 
 
 
For further information please see www.agitherapeutics.com. 
 
 
Notes to Editors: 
 
 
About Rezular(TM) (AGI-003) 
 
 
RezularTM (AGI-003) is an orally administered multiple action intestinal 
regulator. Rezular contains arverapamil, a single enantiomer moiety of the 
racemic drug verapamil. 
 
 
About AGI Therapeutics plc 
 
 
AGI is a specialty pharmaceutical company which is focused on the development 
and commercialisation of differentiated specialty drug products to treat unmet 
medical needs, including conditions which qualify for Orphan drug status. 
 
 
The company has a portfolio of product candidates derived from its Known 
Molecular Entity (KME(TM)) approach to drug re-profiling and development and 
aims to bring its products to the market either directly or through 
out-licensing or other partnering arrangements. 
 
 
AGI's common shares are listed on the Alternative Investment Market of the 
London Stock Exchange (AIM) and on the Irish Enterprise Exchange of the Irish 
Stock Market (IEX) as AGI. 
 
 
 
 
For further information please see www.agitherapeutics.com. 
 
 
Statements contained within this press release may contain forward-looking 
comments which involve risks and uncertainties that may cause actual results to 
vary from those contained in the forward-looking statements. In some cases, you 
can identify such forward-looking statements by terminology such as 'may', 
'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 
'estimates', 'predicts', 'potential', or 'continue'. Predictions and 
forward-looking references in this press release are subject to the satisfactory 
progress of research which is, by nature, unpredictable. Forward projections 
reflect management's best estimates based on information available at the time 
of issue. 
 
 
 
 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
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