Gil Roth12.16.13
The FDA has accepted Shield Therapeutics' IND for a Phase III pivotal trial of ST10, Shield's novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD). The company plans to initiate the study in the U.S. in 1H14; positive data would be the cornerstone of a subsequent NDA submission.
The 16-week prospective, multicenter, randomized, double-blind, placebo-controlled study will enroll approximately 160 pre-dialysis CKD patients in the U.S. who have been diagnosed with IDA. The primary endpoint of the study will be the change in hemoglobin from baseline to week 16.
ST10 is a novel oral ferric iron therapy being developed for the treatment of IDA, which has demonstrated potential as an effective oral alternative to intravenous (IV) iron. As well as showing that gastrointestinal absorption of ST10 is at least as good as ferrous products in previous studies, ST10 has also been shown to have minimal gastrointestinal side effects so can be given on an empty stomach at a much reduced daily dose and to patients who cannot take standard oral iron preparations, for whom the only alternative would be IV infusions of iron. ST10 is not adversely affected by changes in gastric pH, so it may also be effective when co-prescribed with widely used acid-reducers.
ST10 is also currently being investigated in two Phase III trials as a treatment for IDA in inflammatory bowel disease.
The 16-week prospective, multicenter, randomized, double-blind, placebo-controlled study will enroll approximately 160 pre-dialysis CKD patients in the U.S. who have been diagnosed with IDA. The primary endpoint of the study will be the change in hemoglobin from baseline to week 16.
ST10 is a novel oral ferric iron therapy being developed for the treatment of IDA, which has demonstrated potential as an effective oral alternative to intravenous (IV) iron. As well as showing that gastrointestinal absorption of ST10 is at least as good as ferrous products in previous studies, ST10 has also been shown to have minimal gastrointestinal side effects so can be given on an empty stomach at a much reduced daily dose and to patients who cannot take standard oral iron preparations, for whom the only alternative would be IV infusions of iron. ST10 is not adversely affected by changes in gastric pH, so it may also be effective when co-prescribed with widely used acid-reducers.
ST10 is also currently being investigated in two Phase III trials as a treatment for IDA in inflammatory bowel disease.