FDA accepts Shield Therapeutics' IND application to begin ST10 Phase 3 pivotal study for IDA treatment

Published on December 16, 2013 at 3:53 AM · No Comments

Shield Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to initiate a Phase 3 pivotal study 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). The Company plans to initiate the Phase 3 study in the US in H1 2014 and positive data would be the cornerstone of a subsequent NDA submission.

AEGIS 3 will be a pivotal Phase 3, 16-week prospective, multicentre, randomised, double-blind, placebo controlled study and will enrol approximately 160 pre-dialysis CKD patients in the US who have been diagnosed with IDA.  The primary endpoint of the study will be the change in haemoglobin 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 gastro-intestinal 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. As ST10 is not adversely affected by changes in gastric pH, it may also be effective when co-prescribed with widely used acid-reducers.

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