FDA approves study for ST10 in treating Iron deficiency anemia (chronic kidney disease) – Phase-III study
Shield Therapeutics- a separate specialized pharmaceutical organization, targeted on the growth of mineral-derived hospital pharmaceuticals, these days declares that the US FDA has approved its Investigation New Drug (IND) application to start a Phase 3 pivotal research of ST10, its novel oral iron-replacement treatment, for the therapy of iron deficiency anaemia (IDA)
AEGIS 3 will be a critical Phase 3, 16-week prospective, multicentre, randomized, double-blind, placebo managed research and will enroll roughly 160 pre-dialysis CKD sufferers in the US who have been clinically diagnosed with IDA. The main endpoint of the research will be the change in haemoglobin from baseline to week 16.in pre-dialysis sufferers with chronic kidney disease (CKD). The Organization programs to start the Phase 3 research in the US in H1 2014 and beneficial data would be the cornerstone of a subsequent NDA submission.
ST10 is a novel oral ferric iron treatment being designed for the treatment of IDA, which has confirmed potential as an efficient oral alternative to IV iron. As well as displaying that gastrointestinal absorption of ST10 is at least as good as ferrous products in earlier research, ST10 has also been proven to have minimal gastro-intestinal side results so can be given on an empty abdomen at a much decreased daily dose and to sufferers who cannot take conventional oral iron preparations, for whom the only substitute would be IV infusions of iron. As ST10 is not negatively impacted by changes in gastric pH, it may also be efficient when co-prescribed with widely used acid-reducers.
ST10 is also presently being researched in two pivotal Phase 3 research as a therapy for IDA in inflammatory bowel disease, top-line results from which are predicted in the coming months.
Carl Sterritt, Founder and CEO of Shield Therapeutics, mentioned: “I am delighted that FDA has accepted this IND and we can now move ahead with our plans to test ST10 in this 2nd major sign and at the same time present ST10 to clinicians in the world’s largest and most essential pharmaceutical market. ST10 has the potential to be the only efficient oral iron-replacement treatment without important GI side effects and we consider this novel and practical product has the prospective to become a market leader for IDA in the recognized CKD patient population globally.”