Shield Therapeutics, the independent specialty mineral medicines pharmaceutical company, today announces that it has completed recruitment of patients into its pivotal Phase 3 programme of ST10 for the treatment of iron-deficient anaemia. ST10 is a novel form of ferric iron taken orally.
Patients with inflammatory bowel disease and anaemia have been recruited and randomised when oral ferrous products have been ineffective due to intolerance and/or inadequate therapeutic benefit. The primary endpoint of this pivotal international, multi-centre programme is haemoglobin change after 12 weeks' treatment with ST10 compared to placebo. Subjects have been included from expert centres in Austria, Germany, Hungary and the UK and either randomised to receive 30mg of ST10 twice a day, or a matched placebo capsule. Following the randomised treatment period there is an open-label phase that allows all patients to be treated with ST10 for an additional year. Other iron therapies have not been permitted during the study.
Shield Therapeutics expects to report top-line results from the study at the end of Q4 2013 and anticipates these results will provide confirmatory pivotal clinical data that may form the basis of an MAA submission to the European regulatory authorities in 2014. The data is also expected to form part of a subsequent NDA submission in the USA.
Commenting on the study, Professor Gasche, Professor of Medicine, Medical University of Vienna, Austria said:
"Inflammatory bowel disease is one of the most prevalent diseases managed by gastroenterologists. Approximately half of all IBD patients develop iron deficiency and that can readily progress to more severe anaemia, which is the leading cause of fatigue that debilitates day-to-day quality of life. The oral ferrous iron preparations are often poorly tolerated, leaving intravenous iron infusions as the preferred option. However these require significant additional patient time and healthcare resources, hence there is an urgent need for a more convenient solution which we anticipate ST10 may deliver."
Shield Founder and Chief Executive Officer, Carl Sterritt, added:
"We are very grateful to the patients for their commitment, as well as the investigators and their research staff for their hard work and considerable skill that has made this study possible. The completion of recruitment into this pivotal trial is an important step in bringing orally dosed ST10 to market as an effective way of correcting anaemia in patients who cannot tolerate oral ferrous iron therapy and so have to rely on the higher risk option of invasive and resource-consuming intravenous administration of iron."
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