29th Sep 2006 07:01
AGI Therapeutics plc29 September 2006 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 ongastrointestinal (GI) drug products, today announces the preliminary results ofa phase II trial of the Company's espindolol (AGI-001) product candidate for thetreatment of irritable bowel syndrome (IBS). The results of the trial in IBS patients did not show overall efficacy ofespindolol versus placebo when all doses were taken into account. However, theyshowed a positive response at the highest dose level, which the Company believesmay indicate a possible pathway for further development of espindolol in thisindication. AGI will now undertake a more detailed analysis of the data in consultation withits medical advisory board before deciding whether further clinical evaluationis warranted. Commenting on the results, Dr. John Devane, CEO of AGI, said: "There is evidence suggesting that espindolol at the highest dose studied has abeneficial effect on a number of individual IBS symptoms. The drug appeared tohave most positive effects on sensory-related symptoms, as distinct from themore overt bowel movement based symptoms, and therefore espindolol may offer anovel approach to addressing a distinct subset of IBS symptoms. We will reviewthese findings with our medical advisers before determining our futuredevelopment strategy for AGI-001." An earlier phase II study of espindolol in functional dyspepsia, reported by AGIin June, was inconclusive, although this study showed most promise in thesub-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, parallelgroup, forced dose escalation study, which evaluated the efficacy of espindololversus 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 wasdosed in three divided doses as 7.5 mg/day for the first 4 weeks, followed byforced titration (providing the previous dose was well tolerated) to 15 mg/dayfor the next 4 weeks and further dose-escalated (providing the previous dose waswell 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 wererandomised in the study. Using an intent-to-treat analysis of the entire 12weeks of dose-escalation therapy, the espindolol treated patients failed to showany difference from placebo in any of the primary endpoints or secondaryendpoints. However, when considering each titration dose separately, an espindolol dose-response relationship for a number of the efficacy endpoints was detected whilethe placebo groups remained relatively constant for each dose titration step.Significant improvements compared to placebo were noted at the highest dosevisit in change from baseline scores for severity of illness, abdominaldiscomfort/pain, abdominal bloating/distension, and certain individual Qualityof Life subscales (body image and food avoidance). While the overall incidenceof adverse events (AE's) was similar for both espindolol and placebo treatedpatients, there were more withdrawals (including AE related) in the espindololgroup. There were no serious AE's. Contact Information: AGIDavid G. Kelly, Chief Financial OfficerTel: +353 1 449 3254 Financial Dynamics - UKTel: +44 (0) 20 7831 3113Sarah MacLeod Financial Dynamics - IrelandTel: +353 1 663 3607Aisling Garvey 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 beingdeveloped for the treatment of both functional dyspepsia, a functional disorderof 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 normalfunction which cannot be directly attributed to anatomical or biochemicaldefects) that comprises a cluster of gastrointestinal symptoms which are likelyto be life long and can include diarrhoea, constipation, abdominal pain anddistension, which vary in intensity. Altered intestinal motility is a majorcomponent of IBS and patients are diagnosed and sub-typed according to theirpredominant symptom of bowel disturbance as either 'd-IBS',constipation-predominant ('c-IBS') or mixed/alternating symptoms of diarrhoeaand constipation ('m-IBS'). The prevalence of IBS has been estimated in US population-based studies atbetween 10 and 20 per cent and surveys conducted in Europe estimate a similarrange of IBS prevalence there. It is estimated that there is an approximatelyequal prevalence of each of the d-IBS, c-IBS and m-IBS sub-types. IBS isreported to be about twice as prevalent in women as in men. Although anestimated 75 per cent or more of current sufferers remain undiagnosed anduntreated, IBS remains the most common diagnosis made by gastroenterologists andleads to a substantial reduction in quality of life, accompanied by considerablesocio-economic and psychological consequences. About AGI AGI is a speciality pharmaceutical company which is focused on the developmentand 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 KnownMolecular Entity (''KME'') approach to drug re-profiling and development. KME isa re-profiling methodology used by the Company to identify existing therapeuticdrugs which typically have been marketed for a number of years, have establishedsafety profiles and can be developed for new clinical indications or withimproved profiles in their existing clinical indications. In this way, theCompany seeks to reduce the risk, time and cost of new product development ascompared to the development of new chemical entities. AGI is developing a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome, functionaldyspepsia, ulcerative colitis and gastro-esophageal reflux disease. The Companyis targeting areas of the GI therapeutic drug products market for its productcandidates where there are currently unmet medical needs or where theeffectiveness of existing drug therapies can be further improved. The Company has six clinical stage product candidates which are either isomersor new drug delivery formulations of existing approved drugs, and which haveestablished safety and tolerability profiles in their currently approvedclinical 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 theresults of these trials, the Company will initiate late stage development of alead product candidate and will also seek to enter into licensing anddevelopment agreements with pharmaceutical companies so as to enhance the globalmarket reach for its products and achieve optimal revenue and valueopportunities for the Company. Statements contained within this press release may contain forward-lookingcomments that involve risks and uncertainties that may cause actual results tovary from those contained in the forward-looking statements. In some cases, youcan identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions andforward-looking references in this press release are subject to the satisfactoryprogress of research, which is, by nature, unpredictable. Forward projectionsreflect management's best estimates based on information available at the timeof issue. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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