AGI Therapeutics Completes Enrolment of its Phase II Clinical Trial for AGI-001 in Functional Dyspepsia
September 27, 2005 Dublin, Ireland: AGI Therapeutics Ltd., a speciality pharmaceutical company focused in gastroenterology, announced today that it has successfully completed randomisation of 133 patients in a Phase II clinical trial of AGI-001, its lead compound for the treatment of Functional Dyspepsia.
This trial is a multi-centre study being conducted at 12 sites in both male and female patients suffering from Functional Dyspepsia as defined under the ROME II criteria. The trial is being conducted on AGI’s behalf by ICON plc., a leading global provider of clinical services. AGI expects to report this Phase II trial in the first quarter of 2006. AGI is also conducting a Phase II trial with AGI-001 in patients with Irritable Bowel Syndrome ("IBS") which it also expects to complete early next year.
"The successful completion of enrolment for AGI-001 in Functional Dyspepsia represents a major milestone for AGI Therapeutics in its evolution as a speciality pharmaceutical business" said Dr. John Devane, Chief Executive Officer of AGI. "Functional Dyspepsia is a major unmet need in the gastroenterology market and a significant market opportunity for AGI-001 and we look forward to the outcome of this Phase II trial early next year." Dr. Mary Martin, AGI’s Chief Operating Officer added "2005 has been a very busy and successful year for AGI and we have now initiated five different Phase II trials on our products thus far this year across a range of gastrointestinal indications. Additionally, we have initiated the first of three Phase I studies on two further products. AGI-001 is the first of our Phase II programmes to complete enrolment and we expect several other projects to achieve this key milestone over the coming months."
About Functional Dyspepsia
Functional Dyspepsia, also referred to as Non-Ulcer Dyspepsia or "NUD", refers to abnormalities or disturbances of normal function in the upper gastrointestinal tract and manifests as a cluster of symptoms including early satiety, abdominal distention and fullness, epigastric or substernal burning, discomfort and pain. Functional Dyspepsia is a chronic, episodic and highly prevalent condition, affecting up to 25% of the adult population in the US annually, and is associated with a considerable health and economic burden. There are currently no approved drugs for this indication in the US.
About AGI-001
AGI-001 is an isomer of a racemic drug which is marketed for non-gastroenterological indications. AGI-001 emerged as a lead compound from AGI’s KME™ search and development programme to identify novel and improved uses for known drugs in the treatment of gastroenterological diseases and disorders.
The neurotransmitter serotonin (5-HT) has an important role in the regulation of gut physiology, including peristalsis and intestinal tone. AGI Therapeutics has established that AGI-001 is a potent antagonist of 5-HT1A receptors and believes its activity in Functional Dyspepsia is based on this mechanism.
AGI-001 is an isomer of a racemic drug which has been used in millions of patients worldwide and has a well established safety and tolerability profile. AGI-001 is currently being investigated for the treatment of both Functional Dyspepsia and IBS and Phase II trials are ongoing in both these indications. AGI has pending patents for the use of AGI-001 in the treatment of gastrointestinal disorders.
About AGI Therapeutics
www.agitherapeutics.com
AGI Therapeutics Ltd. is a venture capital backed speciality pharmaceutical company, based in Dublin, Ireland, which is engaged in the development of innovative therapeutic products to treat a variety of gastroenterological diseases and disorders.
AGI Therapeutics applies its KME™ model (Known Molecular Entities model) to identify existing drugs or “known molecular entities” with established safety profiles which can be developed and clinically differentiated for gastroenterological indications. KME™-based products offer distinct advantages in terms of the risk, cost and time associated with the development and regulatory process as compared to new molecular entities.
AGI Therapeutics has a portfolio of products at various stages of clinical development which are targeted to provide better and safer therapeutic options for patients in large chronic gastrointestinal markets. AGI’s intellectual property consists of a significant number of granted and pending patents worldwide for new therapeutic uses of known molecules and for improved formulations and presentations.
For further information:
Dr. Mary Martin,
Chief Operating Officer,
Phone:+353 1 449 3250
Mr. Patrick Ashe
Senior Vice President, Business Development
Phone:+353 90 657 1455
Email pashe@agitherapeutics.com
Email mmartin@agitherapeutics.com
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