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Shield Therapeutics' ST10 Delivers Robust Results Meeting both Primary and Secondary Endpoints in the Pivotal AEGIS Phase 3 Programme for the Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease
Date:1/7/2014

LONDON, January 7, 2014 /PRNewswire/ --

~ ST10 strongly demonstrates potential to be (1) the only effective oral treatment for ferrous intolerant IDA patients and (2) an effective alternative to intravenous iron treatment ~

Shield Therapeutics (Shield), an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces strongly positive top-line data from the pivotal Phase 3 programme of ST10 for the treatment of iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD).  

ST10, a novel orally-dosed form of ferric iron, delivered a mean improvement in haemoglobin levels of 2.3g/dL (p <0.0001), clearly meeting the primary endpoint of haemoglobin change after 12 weeks' treatment compared to placebo.  More than 65% of treated subjects experienced normalised haemoglobin levels by week 12 and ST10 also rapidly delivered significant improvements in haemoglobin at 4 weeks (1.1g/dL, p <0.0001) and 8 weeks (1.8g/dL, p <0.0001) of therapy.  From a safety perspective, ST10 did not adversely affect IBD symptoms in treated subjects and was well tolerated for the duration of exposure.

The two AEGIS protocols recruited 128 patients with anaemia secondary to either Crohn's disease or ulcerative colitis who had previously failed therapy with oral ferrous products due to intolerance and/or inadequate therapeutic benefit.  Patients were recruited from expert centres in Austria, Germany, Hungary and the UK and were randomised (1:1) to receive ST10 or a matched placebo capsule.  Other iron therapies were not permitted during the study.  Adverse events recorded during the study were mainly gastrointestinal in nature and occurred in the ST10-treated arm with placebo-like frequency (38% of ST10-treated subjects and 40% of placebo-treated subje
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