Press Releases

Preliminary clinical data for mecamylamine (AGI-004) and arbaclofen (AGI-006)

Dublin, Ireland, 1st February 2007 - AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal drug products, today announces preliminary results of Phase II studies for mecamylamine (AGI-004, for functional diarrhoea) and arbaclofen (AGI-006 for functional dyspepsia). The results of these studies follow the reporting last year of positive results for other AGI products in development.

Both were pilot studies designed to identify clinical signals that would indicate how to proceed to further clinical development. Both studies showed statistical significance in a number of endpoints, which point to their potential clinical utility in certain related GI indications, although the primary endpoints in the specific patient populations were not met. Both products will now be progressed into further clinical trials for related, alternative indications.

Evidence from the mecamylamine study suggests that mecamylamine has a beneficial effect on certain diarrhoea-related symptoms, particularly stool consistency. Based on the signals identified in the current study, the mechanism of action of mecamylamine and the pathophysiology of certain non-functional diarrhoea conditions, this study suggested that mecamylamine may be effective in treating diarrhoea-related symptoms in conditions such as chemotherapy-related diarrhoea. AGI intends to initiate further Phase II clinical evaluation of mecamylamine in the second half of 2007.

The arbaclofen clinical study showed strong evidence that arbaclofen has a beneficial effect on a number of clinically important gastrointestinal symptoms typical of dyspepsia. The symptoms affected appear consistent with the prokinetic activity of arbaclofen and may have particular relevance in the treatment of dyspeptic symptoms associated with gastroparesis in diabetics or with certain sub-sets of the functional dyspepsia population, both of which are important commercial markets. AGI expects to commence a larger and more rigorous Phase II trial in the second half of this year.

Dr. John Devane, CEO of AGI said:

"We are pleased with the positive signals pointing to potential therapeutic benefit in both these compounds and believe further clinical development is justified. The result of these two trials completes the current programme of clinical work on six products which have been evaluated in a variety of GI diseases. The results of the clinical trials on the other four products were reported in 2006. We are highly encouraged with the success we have had so far across our portfolio and can now set out a strategy to progress these products. We look forward to updating our shareholders of these plans in the near future."

Contact Information:

For further information please see www.agitherapeutics.com

Notes to Editors

Mecamylamine (AGI-004)

Preliminary results for mecamylamine in functional diarrhoea:

The clinical trial was a randomised, double-blind, placebo-controlled, parallel-group, forced dose-escalation study which evaluated the efficacy of mecamylamine versus placebo over a 12-week period following an 8-14 day run-in period. Mecamylamine was dosed once daily as 2mg/day for the first 4 weeks, followed by forced titration, providing the previous dose was well tolerated, to 4mg/day for the next 4 weeks and further dose-escalated, providing the previous dose was well tolerated, to 6mg/day for the last 4 weeks of therapy.

82 patients (male and female) meeting ROME II criteria (modified) for functional diarrhoea were randomised in the study. Using an intent-to-treat analysis and the entire 12 weeks of dose-escalation therapy, the mecamylamine treated patients failed to show a statistically significant difference from placebo in the primary and secondary endpoints with the exception of an improvement in stool consistency at week 4 (the 2mg/day treatment period) based on positive responses on at least 50% of the available daily reports.

However, significant improvements in stool consistency with mecamylamine treatment compared to placebo were noted in a smaller modified per-protocol population (n=35) for the entire dose-escalation as well as for each dose treatment phase.

The overall incidence of adverse events (AE's) was similar for both mecamylamine and placebo-treated patients. Three patients (two on mecamylamine and one on placebo) experienced a total of 4 serious AE's all of which were assessed as unrelated to study medication. There were more AE related withdrawals in the mecamylamine group (11) compared with placebo (6).

Arbaclofen (AGI-006)

Preliminary results for arbaclofen in functional dyspepsia:

The clinical trial was a randomised, double-blind, placebo-controlled, parallel-group, forced dose-escalation study, which was designed to evaluate initial signals of efficacy of arbaclofen versus placebo over a 6-week period following an 8-14 day run-in period. Thereafter there was a 1 week down-titration to being drug free. Arbaclofen was dosed in three divided doses as 7.5mg/day for the first 2 weeks, followed by forced titration, providing the previous dose was well tolerated, to 15mg/day for the next 2 weeks and further dose-escalated, providing the previous dose was well tolerated, to 30.0mg/day for the last 2 weeks of therapy.

64 patients (male and female) meeting ROME II criteria (modified) for functional dyspepsia (FD) were randomised in the study. Using an intent-to-treat analysis and the entire 6 weeks of dose-escalation therapy, the arbaclofen treated patients failed to show a statistically significant difference from placebo in the primary endpoint based on patient global impression.

However, the effect of arbaclofen on a number of secondary endpoints was encouraging. More specifically, positive trends in the change from baseline in upper abdominal fullness and early satiety were observed at all study visits (all doses) and in upper abdominal pain/discomfort at the last visit (the highest dose) compared to placebo, while significant improvements were demonstrated for severity of illness, gastrointestinal symptoms, bloating, and nausea at the highest dose visit with trends to improvement in the overall (all visits) treatment response. In addition, significant differences in rescue antacid use were observed at all visits, with the arbaclofen-treated group showing overall lower antacid use. Further differences showing improved quality of life symptom scores for arbaclofen-treated patients were observed at the initial treatment visit for emotional score, the mental health score and the overall mental component summary score with positive trends in the social functioning score and the physical score. Although primary endpoints for functional dyspepsia were not met in this pilot study, the therapeutic benefit was apparent based on the positive effect on numerous secondary endpoints. .

The overall incidence of adverse events (AEs) were similar between the arbaclofen and placebo treated patients, however, the incidence of CNS adverse events (headache, dizziness and somnolence) were greater in the arbaclofen-treated group than the placebo group. There were no serious AEs. The rate of premature withdrawals (drop-outs) was higher in the placebo group (9) than in the arbaclofen-treated group (6).

About AGI

AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastrointestinal (''GI'') diseases and disorders. 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".

The Company has a portfolio of product candidates derived from the Known Molecular Entity (''KME'') approach to drug re-profiling and development. KME is a re-profiling methodology used by the Company to identify existing therapeutic drugs which typically have been marketed for a number of years, have established safety profiles and can be developed for new clinical indications or with improved profiles in their existing clinical indications. In this way, the Company seeks to reduce the risk, time and cost of new product development as compared to the development of new chemical entities.

AGI is developing a range of product candidates to treat a variety of prevalent GI diseases and disorders, including irritable bowel syndrome, functional dyspepsia, ulcerative colitis and gastro-esophageal reflux disease. The Company is targeting areas of the GI therapeutic drug products market for its product candidates where there are currently unmet medical needs or where the effectiveness of existing drug therapies can be further improved.

The Company has six clinical stage product candidates which are either isomers or new drug delivery formulations of existing approved drugs, and which have established safety and tolerability profiles in their currently approved clinical indications. These product candidates are all in clinical development, including five Phase II trials.

AGI intends to complete its ongoing clinical trials and, dependent on the results of these trials, the Company will initiate late stage development of a lead product candidate and will also seek to enter into licensing and development agreements with pharmaceutical companies so as to enhance the global market reach for its products and achieve optimal revenue and value opportunities for the Company.

Statements contained within this press release may contain forward-looking comments that 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.

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