15th Feb 2007 07:01
AGI Therapeutics plc15 February 2007 AGI Therapeutics plc Product update and outlook for 2007 Dublin, Ireland, 15th February 2007 - AGI Therapeutics plc ("AGI" or the"Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused ongastrointestinal drug products, today announces continued progress on keydevelopment programmes and outlines its plans for these programmes in 2007. Following on from the reporting of clinical results on 4 of its products in 2006and the recent reporting, earlier this month, of clinical results on its other 2products, AGI is now in a position to map the next key steps in progressing fiveof the original six products in its pipeline into further clinical development. Arverapamil: • We have requested a meeting with the United States Food and Drug Administration (FDA) to define and agree the full development strategy for our lead product candidate, arverapamil (AGI-003) required to support an NDA submission for irritable bowel syndrome (IBS). We expect to provide guidance on the overall development plan for this product in Q2 2007. • We have now completed the manufacturing of arverapamil drug substance to support anticipated further development requirements and entered into a manufacturing agreement with an FDA-approved manufacturer to supply the arverapamil product for the next phase of clinical testing. We have also recently initiated a Phase I pharmacokinetic study to further define the pharmacokinetics of arverapamil. Omeprazole: • We have initiated a Phase II combined pharmacokinetics and pharmacodynamics study of our controlled release omeprazole (AGI-010) product for gastro-esophageal reflux disease (GERD) with our partner Axcan Pharma Inc (Axcan), and expect to report results in Q2 2007. 4-ASA • We have decided to advance 4-ASA (AGI-004) into Phase II clinical development for ulcerative colitis (UC) and are currently evaluating the design and scope of this study. Mecamylamine and Arbaclofen • We recently reported results for controlled release mecamylamine (AGI-004) and arbaclofen (AGI-006) and given that promising data we are now evaluating the potential use of these two products in chemotherapy-induced diarrhoea and diabetic gastroparesis respectively. Espindolol • As indicated in September and following consultation with our medical advisory panel and other experts, and given the high levels of activity expected with our other programmes, we have decided not to pursue further development of espindolol (AGI-001) in either functional dyspepsia or IBS. Commenting on the update, Dr John Devane, CEO of AGI said: "2007 promises to be an exciting year for AGI as we are set to make furtherprogress in the clinic. Following on from the positive outcome of the Phase IItrial which we completed last year we are now preparing to move arverapamil intothe next phase of clinical development in the treatment of IBS. We havecompleted proof of concept clinical evaluation on all of the other products inour current portfolio and, with the exception of espindolol, believe theencouraging results reported to date warrant further clinical development. Inaddition to our commitment to move forward aggressively during the year with thearverapamil and omeprazole programmes, we plan to progress Phase II clinicalevaluation of our other pipeline products. "Furthermore, our recent agreement with Axcan demonstrates both our willingnessto partner and our desire to continue to be directly involved in the developmentof our products. Such agreements also enable us to achieve our strategic goalof evolving AGI as an integrated speciality pharmaceutical company in the futurethrough retaining co-promotion and other marketing rights." Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254David Kelly, Chief Financial Officer Financial Dynamics - UK Tel: +44 (0) 20 7831 3113Anna Keeble Financial Dynamics - Ireland Tel: +353 1 663 3607Aisling Garvey For further information please see www.agitherapeutics.com Update on key Clinical Research Programmes Arverapamil (AGI-003) Following the reporting of positive Phase II results of this product in thetreatment of non-constipation dominant IBS in May 2006, AGI has completedevaluation of all of the clinical data and reviewed the results with its medicaladvisory panel (see Press Release January 22, 2007). AGI believes that theclinical results demonstrate a robust therapeutic profile for IBS with strongsignals of therapeutic benefit in both primary and secondary end-points with agood safety profile. AGI has requested a meeting with the United States FDA to define and agree thefurther development strategy for this product which will be required to supportan NDA submission. Based on the specific requirements of the FDA, the Companyexpects to provide guidance on the overall development plan for this product inQ2 2007. AGI has recently taken receipt of sufficient quantities of arverapamil drugsubstance to support its anticipated further development requirements. Inaddition, AGI has entered into a scale-up and manufacturing contract with anFDA-approved US-based manufacturer to supply AGI's arverapamil productrequirements for future development activities. AGI has recently initiated aPhase I study in order to better define the pharmacokinetics of arverapamil. Dr David Young, AGI's President of US operations, commented on the upcomingmeeting; "The meeting with the US Food and Drug Administration is the next critical stepin progressing arverapamil development along the path to an NDA. We havediligently spent the time, since the release of the preliminary Phase IIresults, further analysing the data and discussing with expert clinicians howbest to design the next clinical development phase for this compound. Wecontinue to be very excited by the potential of arverapamil and are anxious toensure that the next phase of development is designed to meet the requirementsand expectation of regulatory agencies, clinicians and ultimately, patients." Omeprazole (AGI-010) AGI entered into a co-development and license agreement with Axcan Pharma Inc.in Sept 2006 to jointly develop a controlled release omeprazole product based onAGI's CHRONAB formulation approach for North American markets. AGI is workingclosely with Axcan to progress omeprazole through the current Phase II productoptimisation. AGI has recently initiated a Phase II combined humanpharmacokinetics and pharmacodynamics study in normal human volunteers toconfirm the in-vivo drug release and pharmacokinetics as well as theintra-gastric pH profiles of an optimised CHRONAB formulation of omeprazole andexpects to report the results of this study in Q2 2007 . Thereafter, AGI andAxcan plan to submit a request for a meeting with the FDA to define and agreethe final phase of development for this product. 4-ASA (AGI-022) Based on the positive Phase I results reported in 2006, AGI has decided toprogress this product into Phase II clinical evaluation for the treatment ofulcerative colitis (UC). The goal of the planned Phase II study will be toconfirm the efficacy/dosage advantages of the product in UC patients.Formulation development work and scale-up of manufacture is now underway and thePhase II trial design is being finalised. Mecamylamine (AGI-004) Preliminary results for controlled release mecamylamine in Functional Diarrhoeawere reported recently (February 1, 2007) The results demonstrated a strong signal in improved stool consistency inFunctional Diarrhoea patients but without a matching response in patient globalimpression. AGI believes that controlled release mecamylamine has the potentialto be an effective agent in diarrhoeal states characterised by a high frequencyof watery stools. Given the mechanism of action of mecamylamine on nAChR(nicotinic acetylcholine) receptors and the pathophysiology of certaindiarrhoeal states which are not satisfied by current therapy, AGI has identifiedchemotherapy-induced diarrhoea (CID) as an area of unmet clinical need wherecontrolled release mecamylamine may have therapeutic benefit and is finalisingplans to progress into Phase II clinical development for this indication. Arbaclofen (AGI-006) Preliminary results for arbaclofen in Functional Dyspepsia were reportedrecently (February 1 2007). The results demonstrated a robust profile of beneficial effects on a range ofdyspeptic symptoms but without a matching response in patient global impression.Functional Dyspepsia continues to represent a difficult indication to translatedrug activity into a global response. The sub-classification of functionaldyspepsia in ROME III reflects this continuing difficulty and may offer astrategy for further development in this indication in the future. AGI has determined that the profile of activity of arbaclofen in variousdyspeptic symptoms matches well with the desired profile of a therapy for thedyspeptic symptoms of gastroparesis. Diabetic gastroparesis is the most commonmanifestation of the dyspeptic symptoms of gastroparesis, however effective andwell-tolerated therapy options are extremely limited for these patients. AGI isnow finalising plans for further Phase II clinical development forgastroparesis. Espindolol (AGI-001) Preliminary results of two clinical trials that examined espindolol inFunctional Dyspepsia (FD) and Irritable Bowel Syndrome (IBS) have been reportedto date. Based on further data analysis, AGI has determined that the results ofthe FD trial were inconclusive and did not demonstrate any convincing signals ofactivity. In the IBS trial, espindolol failed to meet primary endpoints althoughsome limited positive signals were observed at the higher dose levels. However,having reviewed these results with our Medical Advisory Board, we have concludedthat these signals were not sufficiently compelling to support furtherdevelopment of this product in either of these indications. About AGI Therapeutics plc 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 AlternativeInvestment Market of the London Stock Exchange ("AIM") and on the IrishEnterprise 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 has developed a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,ulcerative colitis and gastro-esophageal reflux disease (GERD). The Company istargeting 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 clinical stage product candidates which are either isomers ornew drug delivery formulations of existing approved drugs, and which haveestablished safety and tolerability profiles in their currently approvedclinical indications. AGI intends to complete its ongoing clinical trials and, dependent on theresults of these trials, the Company will initiate late stage clinicaldevelopment of lead product candidates and will also seek to enter intolicensing and development agreements with pharmaceutical companies so as toenhance the global market reach for its products and achieve optimal revenue andvalue opportunities for the Company. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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