Firm has initiated a Phase Ib study in the U.S. involving cancer patients.

ActoGeniX received a $1.3 million grant from the Flemish government to support clinical development of its oral mucositis drug candidate, AG013. The company has already started a U.S. Phase Ib trial in cancer patients at risk of developing oral mucositis.

The grant has been made through the Flemish government’s Institute for Promotion of Innovation and Science and Technology in Flanders.

AG013 is an ActoBiotic™ developed using ActoGeniX’ TopAct™ technology. The oral rinse product delivers a specific human trefoil factor to gastrointestinal (GI) tissue to prevent and help heal oral mucositis in cancer patients.

ActoGeniX’s ActoBiotic drug candidates are designed to be delivered via oral administration and specifically target receptors and cells localized in GI tissues. The company says the TopAct technology allows almost any nonglycosylated protein or peptide to be engineered and formulated into an ActoBiotic within four to six weeks.

Lead product, AG011, is an IL-10 ActoBiotic in development for the treatment of inflammatory bowel diseases. The candidate is currently being evaluated in a Phase II study involving ulcerative colitis patients. AG011 was successfully tested in a Phase I trial in Crohn’s disease, and ActoGeniX says that it will continue development in this indication. 

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