Product pipeline

Applying the versatile TopAct™ technology platform, ActoGeniX researchers have created a collection of more than 50 different ActoBiotics™ over the last few years. Choosing only the most promising leads, ActoGeniX has developed a rich and diverse pipeline, comprising products at clinical, preclinical and discovery stage. ActoGeniX’s initial focus is on areas with unmet need in gastrointestinal, immunological and metabolic diseases.

 

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ActoGeniX’s lead product, AG013, is an ActoBiotic&trade; for the treatment of oral mucositis (OM). OM is among the most frequently reported adverse events associated with cancer treatment, and is estimated to affect nearly 0.5 million individuals each year in the United States alone.

In May 2009, the FDA approved ActoGeniX’s IND application, allowing the Company to initiate a phase 1B clinical trial with AG013 in cancer patients at risk of developing oral mucositis. Meanwhile, ActoGeniX has started this clinical study in collaboration with several reputed oncology centers in the US. The primary aim of the study is to evaluate safety and tolerability of AG013, but it will also allow collection of initial efficacy data.

Based on data obtained with AG011, ActoGeniX’s first product for the treatment of inflammatory bowel, in a phase 2 clinical trial in ulcerative colitis patients, ActoGeniX is further developing an optimized formulation of Actobiotics secreting anti-TNFalpha monoclonal antibodies for the treatment of inflammatory bowel disease.

Other programs in preclinical stage, for which ActoGeniX and its collaborators have already obtained positive in vivo efficacy data, include celiac disease, type 1 and 2 diabetes, and allergic diseases.