The US Food and Drug Administration (FDA) has accepted Shield Therapeutics' Investigational New Drug (IND) application to initiate a phase III 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 is an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals.

The company also plans to initiate the phase III 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 III, 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.

ST10 is also currently being investigated in two pivotal phase III studies as a treatment for IDA in inflammatory bowel disease, top-line results from which are expected in the coming months.

Carl Sterritt, founder and chief executive officer of Shield Therapeutics, stated: “I am delighted that FDA has approved this IND and we can now move forward with our plans to test ST10 in this second major indication and at the same time introduce ST10 to clinicians in the world’s largest and most important pharmaceutical market. ST10 has the potential to be the only effective oral iron-replacement therapy without significant GI side effects and we believe this novel and convenient product has the potential to become a market leader for IDA in the established CKD patient population worldwide.”