Speciality mineral medicines pharmaceutical company Shield Therapeutics has completed patient recruitment in its Phase 3 programme of oral ST10, a novel form of ferric iron, for the treatment of iron-deficient anaemia.
The study recruited and randomised inflammatory bowel disease and anaemia patients, in whom oral ferrous products were ineffective due to intolerance and/or inadequate therapeutic benefit.
Shield founder and chief executive officer Carl Sterritt said, "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."
Subjects included from centres in Austria, Germany, Hungary and the UK are randomised with either 30mg of ST10 two times each day, or a matched placebo capsule.
The pivotal international, multi-centre programme's primary endpoint is the haemoglobin change after a 12-week treatment with ST10 compared with placebo.
In the study, which does not permit other iron therapies, an open-label phase subsequent to the randomised treatment period allows treatment of all patients with ST10 for an added year.
Medical University of Vienna professor of medicine Professor Gasche said that intravenous iron infusions are the preferred option for many inflammatory bowel disease patients with iron deficiency.
"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," Gasche added.
Top-line study results, which are expected at the end of the fourth quarter of 2013, are anticipated to support MAA submission to the European regulatory authorities in 2014 along with subsequent NDA submission in the US.