Shield Posts Positive IDA/IBD Results

Shield Therapeutics has posted positive top-line data from the pivotal Phase III program of ST10 for the treatment of iron deficiency anemia (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, meeting the primary endpoint of hemoglobin change after 12 weeks’ treatment compared to placebo. More than 65% of treated subjects experienced normalized hemoglobin levels by week 12 and ST10 also rapidly delivered significant improvements in hemoglobin at four weeks and eight weeks 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 protocols recruited 128 patients with anemia 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 centers in Austria, Germany, Hungary and the UK and were randomized (1:1) to receive ST10 or a matched placebo capsule.

The results provide confirmatory pivotal clinical data which will form the basis of a MAA submission to the European regulatory authorities during 2014. In conjunction with data that will be generated from an ongoing study of ST10 in the treatment of IDA in pre-dialysis chronic kidney disease patients, these results will also form part of an NDA submission to the FDA.