Shield Therapeutics (Shield), the independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address areas of high unmet medical need, today 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).
"Following our successful fundraising in June, we are delighted to have now treated the first patients in the AEGIS Phase 3 programme and we remain on course to have top line results from these studies in late 2012. Effective treatment of IDA represents a very attractive commercial opportunity and the start of recruitment is an important milestone for Shield Therapeutics as we continue the rapid development of ST10 to address this significant unmet need for the many patients with IDA." said Carl Sterritt, Chief Executive Officer and Co-Founder of Shield Therapeutics.
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.
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 Crohn's 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.
Data provided by IMS suggests that the iron market was worth $2.4 billion in 2010, of which 55% of revenues were generated from oral iron therapies.
There are currently no curative treatments available for UC or Crohn's and so treatment options are restricted to controlling symptoms, maintaining remission and preventing relapse. IDA in both is a chronically debilitating disorder which has a significant impact on patients' quality of life and, as a result, its treatment is an important aspect of disease management. Characteristic symptoms of IDA include chronic fatigue, headache and subtle impairment of cognitive function. Up to one third of subjects with UC and Crohn's suffer from recurrent anaemia, with hospitalisation required in severe cases.