SynCo Bio Partners B.V., has announced that it has completed the manufacture and release of ActoGeniX’ drug substance AG011 for use in a Phase II clinical trial with ulcerative colitis patients.
ActoGeniX is focused on the development and commercialization of ActoBiotics™, a novel class of protein-based biopharmaceuticals that can be orally administered.
The Company’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.
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 lyophilization of AG011. Although the project involved several parties, working virtually simultaneously on different aspects, the GMP batches were produced within the agreed timelines.
Announcing the successful completion of the project, Pierre Warffemius, CEO, said, “Having ActoGeniX choose us to manufacture the GMP batches for their Phase II clinical trials is a clear endorsement of our growing reputation for manufacturing live biopharmaceuticals. The fact that we were able to work on a multi-agency project and deliver the drug substance on time is also an excellent example of project management capabilities.”
Mark Vaeck, CEO of ActoGeniX, “The move from Phase I to Phase II clinical trials is a critical step for ActoGeniX so it was imperative that we worked with a GMP-accredited contract manufacturing organization that had a proven track record in developing processes for biopharmaceuticals, as well as commercial manufacturing capabilities”
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.