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news.SynCo Bio Partners, a GMP biopharmaceutical manufacturer, has completed the manufacture and release of ActoGeniX's drug substance AG011 for use in a Phase II clinical trial with ulcerative colitis patients.
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ActoGeniX’s lead product AG011 is an ActoBiotic for treatment of inflammatory bowel disease and has previously been successfully tested in a Phase I clinical trial with Crohn’s disease patients. ActoGeniX will, in the coming weeks, file the regulatory applications to obtain approval for the start of its AG011 clinical trial during this summer. ActoGeniX also plans to start a Phase II study with the same product in Crohn’s disease patients in the course of 2009.
To provide the AG011 drug product required for the Phase II studies, due to start this summer, SynCo has developed and scaled up the manufacturing process involving cultivation, purification and lyophilisation of AG011. Although the project involved several parties, working virtually simultaneously on different aspects, the GMP batches were produced within the agreed timelines.