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AGI Therapeutics announces preliminary results of phase II trial of espindolol (AGI-001) in irritable bowel syndrome.

Dublin, Ireland, 29 September, 2006 - AGI Therapeutics plc (AIM, IEX: AGI, "AGI" or the "Company"), a speciality pharmaceutical company focused on gastrointestinal (GI) drug products, today announces the preliminary results of a phase II trial of the Company's espindolol (AGI-001) product candidate for the treatment of irritable bowel syndrome (IBS).

The results of the trial in IBS patients did not show overall efficacy of espindolol versus placebo when all doses were taken into account. However, they showed a positive response at the highest dose level, which the Company believes may indicate a possible pathway for further development of espindolol in this indication.

AGI will now undertake a more detailed analysis of the data in consultation with its medical advisory board before deciding whether further clinical evaluation is warranted.

Commenting on the results, Dr. John Devane, CEO of AGI, said:

"There is evidence suggesting that espindolol at the highest dose studied has a beneficial effect on a number of individual IBS symptoms. The drug appeared to have most positive effects on sensory-related symptoms, as distinct from the more overt bowel movement based symptoms, and therefore espindolol may offer a novel approach to addressing a distinct subset of IBS symptoms. We will review these findings with our medical advisers before determining our future development strategy for AGI-001."

An earlier phase II study of espindolol in functional dyspepsia, reported by AGI in June, was inconclusive, although this study showed most promise in the sub-set of patients with the most severe manifestation of symptoms.

Clinical Trial Results Summary - Espindolol (AGI-001)

The clinical trial was a randomised, double-blind, placebo-controlled, parallel group, forced dose escalation study, which evaluated the efficacy of espindolol versus placebo over a 12-week period following an 8-14 day run-in period. Thereafter, there was a 1 week down-titration to being drug free. Espindolol was dosed in three divided doses as 7.5 mg/day for the first 4 weeks, followed by forced titration (providing the previous dose was well tolerated) to 15 mg/day for the next 4 weeks and further dose-escalated (providing the previous dose was well tolerated) to 22.5 mg/day for the last 4 weeks of therapy.

67 patients (male and female) meeting ROME II criteria (modified) for IBS were randomised in the study. Using an intent-to-treat analysis of the entire 12 weeks of dose-escalation therapy, the espindolol treated patients failed to show any difference from placebo in any of the primary endpoints or secondary endpoints.

However, when considering each titration dose separately, an espindolol dose- response relationship for a number of the efficacy endpoints was detected while the placebo groups remained relatively constant for each dose titration step. Significant improvements compared to placebo were noted at the highest dose visit in change from baseline scores for severity of illness, abdominal discomfort/pain, abdominal bloating/distension, and certain individual Quality of Life subscales (body image and food avoidance). While the overall incidence of adverse events (AE's) was similar for both espindolol and placebo treated patients, there were more withdrawals (including AE related) in the espindolol group. There were no serious AE's.

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For further information please see www.agitherapeutics.com

NOTES TO EDITORS

About Espindolol (AGI-001) and IBS

Espindolol is an oral dosage form of the S-isomer of pindolol which is being developed for the treatment of both functional dyspepsia, a functional disorder of the upper GI tract, and irritable bowel syndrome (IBS) in both men and women.

IBS is a functional disorder (i.e. an abnormality or disturbance of normal function which cannot be directly attributed to anatomical or biochemical defects) that comprises a cluster of gastrointestinal symptoms which are likely to be life long and can include diarrhoea, constipation, abdominal pain and distension, which vary in intensity. Altered intestinal motility is a major component of IBS and patients are diagnosed and sub-typed according to their predominant symptom of bowel disturbance as either 'd-IBS', constipation-predominant ('c-IBS') or mixed/alternating symptoms of diarrhoea and constipation ('m-IBS').

The prevalence of IBS has been estimated in US population-based studies at between 10 and 20 per cent and surveys conducted in Europe estimate a similar range of IBS prevalence there. It is estimated that there is an approximately equal prevalence of each of the d-IBS, c-IBS and m-IBS sub-types. IBS is reported to be about twice as prevalent in women as in men. Although an estimated 75 per cent or more of current sufferers remain undiagnosed and untreated, IBS remains the most common diagnosis made by gastroenterologists and leads to a substantial reduction in quality of life, accompanied by considerable socio-economic and psychological consequences.

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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