29th Mar 2006 07:01
AGI Therapeutics plc29 March 2006 AGI Therapeutics plc reports results of clinical studies for two product candidates Dublin, Ireland, 29th March 2006 - AGI Therapeutics plc ("AGI" or the"Company"), a speciality pharmaceutical company focused on gastrointestinal drugproducts, today reported the outcome of a clinical study on its AGI-022 productcandidate and preliminary data from a clinical study on its AGI-010 productcandidate. Both product candidates are modified release oral formulations ofexisting drugs used to treat gastrointestinal diseases. Details of the Clinical Studies AGI-022 AGI-022 is a delayed/controlled release oral formulation of 4-aminosalicylatesodium ("4-ASA-Na"), which AGI believes will be effective in the treatment ofulcerative colitis. AGI-022 is designed to release 4-ASA-Na in the lowergastrointestinal tract and so optimise the delivery of the drug to the affectedsites in ulcerative colitis. Ulcerative colitis is a chronic, recurrent, relapsing and remitting inflammatorydisease of the colon and/or rectum, and its prevalence is estimated at almost 1million patients across the seven major pharmaceutical markets (US, Japan,Germany, UK, France, Italy and Spain) and the incidence of new cases in thesecountries is estimated at 50,000 per annum. The aminosalicylate class ofanti-inflammatory drugs is used to treat ulcerative colitis and many of thosecurrently marketed are presented as modified release oral formulations. 4-ASA isan aminosalicylate drug which is not currently available in an oral modifiedrelease form for the treatment of ulcerative colitis. Global annual sales ofaminosalicylate drug products used to treat inflammatory bowel diseases such asulcerative colitis are currently estimated to be at least US$700 million. AGI has completed and is now fully reporting on a human pharmacokinetics studyin 16 healthy human subjects designed to characterise the in-vivo drug releaseprofiles of three delayed release/ controlled release formulations of AGI-022compared with a reference solution of 4-ASA-Na. Each study formulation wasgiven as a single 250mg dose. The study demonstrated delayed in-vivo releaseprofiles that correlated with the different in-vitro release patterns of thethree formulations of AGI-022. In addition, the AGI-022 formulations achievedmarkedly reduced peak plasma levels (Cmax), and a reduced ratio of parent ASA ton-Acetyl metabolite levels, confirming the controlled release profile of theformulations. Based on the plasma level and urinary excretion profiles observed in this study,one of the current formulations has been selected as optimal and will be thebasis of future clinical development. AGI believes that AGI-022 may offercertain advantages compared with currently marketed 5-aminosalicylate ("5-ASA")therapies, including; a superior tolerability profile, a more reliable andtargeted delivery to the affected sites in ulcerative colitis and a moreefficient therapy with potential dose-sparing versus currently marketed 5-ASAtherapies. Based on its controlled release profile, it is anticipated thatAGI-022 would be dosed twice daily. AGI is now seeking to enter into licensing agreements for AGI-022 withpharmaceutical marketing partners in order to complete development andregistration of the product. AGI-010 AGI-010 is a delayed/controlled release formulation of the proton pump inhibitordrug ("PPI"), omeprazole, which AGI believes will be effective in treatingnocturnal acid breakthrough ("NAB"), a prevalent aspect of gastro-esophagealreflux disease ("GERD"). GERD is the most common of the major gastrointestinal disorders and itsprevalence in the general population is estimated to range from 20 to 40 percent. Proton pump inhibitors are commonly used drugs in the treatment of GERDand are one of the largest selling drug classes with global annual sales inexcess of US$20 billion. NAB is estimated to occur in more than 70 per cent ofh.pylori-negative and in up to 50 per cent of h.pylori-positive patients on PPItherapy and modification of the dosage regime of existing PPIs has only hadlimited success in controlling the symptoms of NAB despite improving acidsuppression. AGI has developed CHRONAB, an approach to the formulation of PPIs, tospecifically address NAB. AGI's lead CHRONAB product candidate is AGI-010,which is a delayed/controlled release formulation of omeprazole, one of the mostcommonly prescribed PPI drugs. AGI-010 is designed to be taken once-daily atnight-time and align PPI drug exposure with the period of NAB (typicallymidnight to 6am). AGI has completed a combined human pharmacokinetics and pharmacodynamics studyin 16 healthy human subjects to characterise the in-vivo drug release and theintra-gastric pH profiles of three delayed release/ controlled release CHRONABformulations of AGI-010 given as 40mg once-daily at bedtime (fasted) compared tomarketed omeprazole (PrLosec(R)) given as 20mg twice-daily morning and eveningbefore meals. Each study formulation was dosed for five consecutive days.Preliminary data from the study demonstrates that each of the three AGI-010formulations achieved a delayed/controlled release profile with a marked delayin the time-course of in-vivo release resulting in peak drug exposure (Tmax) at7.8 hrs, 7.6 hrs and 8.6 hrs respectively post-dosing. Based on these results,AGI believes that the time course of drug release from the current formulationsis over-extended and the release profile of AGI-010 will now be optimised toachieve a better alignment of drug release and absorption with the target NABperiod (12 midnight to 6 am). Commenting on the outcomes of these clinical studies, Dr. John Devane, ChiefExecutive Officer of AGI, said: "We are very pleased with the final outcome of the clinical study on AGI-022. Weare also encouraged by the preliminary data from the clinical study on AGI-010and will now proceed to optimise a lead formulation from this study for furtherclinical testing. We believe that each of these products offers potentialimprovements to current therapy in ulcerative colitis and nocturnal acidbreakthrough in GERD patients respectively and will target significantopportunities in these markets. We will now seek to out-license the commercialrights to AGI-022 so that the further stages of the development and regulatoryprocess for this product can be completed in co-operation with marketingpartners. In the case of AGI-010, we plan to complete the optimisation of alead formulation and a confirmatory human pharmacokinetics and pharmacodynamicsstudy by year end." Contact Information AGI Therapeutics Tel: +353 9064 71455 Patrick Ashe, Senior VP, Business Development Financial Dynamics - UK Tel: +44 (0) 20 7269 7148 Sarah MacLeod Financial Dynamics - Ireland Tel: +353 1 663 3607 Aisling Garvey www.agitherapeutics.com About AGI Therapeutics AGI is a speciality pharmaceutical company which is focused on the developmentand commercialisation of differentiated drug products for gastrointestinal (''GI'') diseases and disorders. 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 has developed 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 Phase III 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. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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