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Trials & Filings

Shield Proposes IDA-CKD Trial

Files to begin Phase III trial of oral iron-replacement therapy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Shield Therapeutics has filed an IND application with the FDA to initiate a Phase III trial of ST10, its novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD).

ST10 is a novel oral ferric iron therapy being developed for the treatment of iron deficiency. It has demonstrated potential as an effective oral alternative to parenteral (IV) iron in ferrous-intolerant patients. Previous clinical studies have shown that gastrointestinal absorption of ST10 is at least as good as ferrous products. Because ST10 has minimal gastro-intestinal side effects, it can be given on an empty stomach and at a significantly lower daily dose. As ST10 is not adversely affected by changes in gastric pH, it can also be co-prescribed with widely used acid-reducers.

Shield is proposing a 16-week prospective, multicenter, randomized, double-blind, placebo controlled study that will enroll pre-dialysis CKD patients in the U.S. who have a diagnosis with iron deficiency anaemia. ST10 is also currently being investigated in a Phase III study as a potential treatment for IDA in inflammatory bowel disease, with top-line results expected towards the end of 2013.

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