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news.AGI Therapeutics has completed the optimization phase of development of AGI-010, a modified release formulation of the proton pump inhibitor drug omeprazole, which utilizes AGI's Chronab technology.
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As part of the optimization phase of development, AGI completed a number of studies in healthy human volunteers. These studies characterized the drug release profile, the pharmacokinetics of omeprazole and the intragastric pH following administration of a number of prototype formulations of AGI-010.
Based on the outcome of these studies, a formulation has been identified which could have the potential to control intragastric pH during the night.
AGI entered into a co-development and licence agreement with Axcan Pharma in September 2006, to jointly develop AGI-010 for North American markets.
John Devane, CEO of AGI, said: “We believe we have identified a unique formulation of omeprazole for once daily administration which could specifically address nocturnal acid breakthrough (NAB), a real unmet medical need for gastroesophageal reflux disease (GERD)patients. With our partner, Axcan Pharma, we will now focus on defining the appropriate development approach for the remainder of the AGI-010 program.”