Shield Therapeutics has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to begin a Phase III trial of its novel oral ferric iron-replacement therapy ST10 for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD).
ST10 is being developed to treat iron deficiency, which has showed potential as an effective oral alternative to parenteral (IV) iron in ferrous intolerant patients.
According to previous clinical trials, gastrointestinal absorption of ST10 is at least as good as ferrous products, and a lower daily dose can be given on an empty stomach as it has minimal gastro-intestinal side effects.
The company said that ST10 is not adversely affected by changes in gastric pH and it can be co-prescribed with widely used acid-reducers.
The British National Formulary states ‘parenteral iron does not produce a faster response than oral iron provided the oral iron is taken reliably and is absorbed adequately’.
In addition to avoiding the inconvenience, high-cost and life-threatening hypersensitivity risks associated with IV infusions, ST10 aims to provide this compelling alternative to prescribers, patients and payors.
The 16-week prospective, multicentre, randomised, double-blind, placebo controlled Phase III trial is also known as AEGIS 3 study.
Pre-dialysis CKD patients in the US who have a diagnosis with iron deficiency anaemia will be enrolled in the trial of ST10.
ST10 is currently being investigated in a Phase III trial as a potential treatment for IDA in inflammatory bowel disease and the top-line results are scheduled to be released by the end of the year.
Shield Therapeutics founder and chief executive officer Carl Sterritt said: "We believe the benefits ST10 will deliver to patients with CKD who cannot tolerate oral ferrous iron therapy, coupled with the convenient nature of its administration, will make ST10 a leader in the future treatment paradigm of IDA in CKD."