Trials & Filings

Shield Posts Positive IDA/IBD Results

Will file MAA in 2014, with NDA to follow

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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...

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