Product pipeline
Applying the versatile TopAct™ technology platform, ActoGeniX researchers have created a collection of more than 100 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™ 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 finalized this clinical study in collaboration with several reputed oncology centers in the US. The primary aim of the study was to evaluate safety and tolerability of AG013, but also to collect initial efficacy data. AG013 was proven to be safe and well tolerated. Analysis of initial efficacy showed a 35% reduction of the percentage of days with ulcerative oral mucositis in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of the patients treated with AG013 were full responders while all placebo-treated patients developed ulcerative oral mucositis.
ActoGeniX is further developing a range of ActoBiotics™ expressing and secreting different bio-therapeutics such as anti-TNFalpha monoclonal antibodies (inflammatory bowel disease), IL-27 (inflammatory bowel disease, celiac disease), toxin-neutralizing antibodies (Clostridium difficile-associated enteropathy), and antigens (celiac disease, type 1 diabetes).