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Clinical Development AST-120: Fistulizing Crohn’s Disease AST-120 is a selective, spherical carbon adsorbent, for oral administration. The compound has been investigated in a Phase 2/3 clinical trial in fistulizing Crohn’s disease in Japan. At the Digestive Disease Week meeting held in May 2006, Dr. Fukuda presented data from a Phase 2/3 double-blind, placebo-controlled Japanese clinical trial in Crohn’s disease patients with fistulas. The data demonstrated a significant reduction in the number of draining fistulas in patients treated with AST-120 compared with placebo. Subsequently, another set of data in fistulizing Crohn’s disease was presented by Dr Fukuda at the UEGW meeting in Berlin in October 2006. AST-120: A Platform in a Drug AST-120, an oral adsorbent, is not absorbed into the blood stream and acts locally in the GI tract to treat systemic GI/liver diseases. The result is a product which has non-overlapping mechanisms of action for currently available therapeutic options in IBD with a well-established safety profile. AST-120 has been demonstrated, to-date, not to interact with concomitant medications as long as it is administered ½ hr apart from the other medications. Preclinical studies have demonstrated that AST-120 selectively adsorbs a number of substances putatively involved, directly or indirectly, in the pathogenesis of chronic inflammatory GI and liver diseases, while not significantly binding digestive enzymes or fat-soluble vitamins involved in patient nutritional balance. Based on its pharmacodynamic properties, AST-120 has a potential to address a range of conditions beyond Crohn’s disease, including Irritable Bowel Syndrome (IBS), Pouchitis, PPI-resistant GERD, and liver diseases such as Hepatic Encephalopathy. Ocera has initiated four Phase 2 Proof of Concept trials in these indications.
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