Date: 2011-10-12
Type of information:
phase: 3
Announcement: treatment of the first patient
Company: Shield Therapeutics (UK)
Product: ST10
Action
mechanism: ST10 is an oral ferric iron-based pharmaceutical that can be administered to patients with improved tolerability compared to currently marketed oral iron treatments and also does not carry the risk of hypersensitivity reactions as is the case with currently marketed intravenous iron therapies. Whilst prescribers often try oral ferrous products as first line therapy, many subjects prove intolerant and suffer from continuously occurring side effects, exacerbation of inflammatory lesions and failure to correct iron deficiency. This results in the need for expensive, complicated and invasive intravenous iron therapy. When treated with ST10, the total dose exposure of unabsorbed iron within the gastrointestinal tract is significantly reduced and, as the iron is retained within the product if it is not absorbed, it is expected this will significantly reduce the risk of unwanted side effects within the gastrointestinal tract.
Disease: iron deficiency anaemia (IDA) in subjects with inflammatory bowel disease (IBD).
Therapeutic area: Hematological diseases - Inflammatory diseases
Country: international study
Trial
details: The international, multicentre, randomised, double-blind and placebo controlled AEGIS 1 and AEGIS 2 studies will investigate the potential of ST10 as a twice-daily treatment of IDA in subjects with Ulcerative Colitis (UC) or Crohns disease respectively where oral ferrous preparations have failed or cannot be used. The studies are each enrolling 120 patients and will measure patients change in haemoglobin concentration from baseline to week 12. Initial results from both studies are expected to be reported in late 2012 and, if positive, will be promptly followed by filings of marketing authorisation applications in key pharmaceutical markets. In addition, Shield is planning to initiate a Phase 3 study of ST10 for the treatment of IDA in patients with chronic kidney disease in 2012.
Latest
news: Shield Therapeutics has announced that the first patients have been treated in the two Phase 3 clinical studies of ST10 for the treatment of iron deficiency anaemia (IDA) in subjects with inflammatory bowel disease (IBD).
