Feraccru fails AEGIS-CKD pivotal Phase III study to treat iron deficiency anemia. - Shield Therapeutics.

Shield Therapeutics plc announces top line results from its AEGIS-CKD pivotal Phase III study of Feraccru. Feraccru is a novel oral ferric iron therapy that has been approved and marketed in Europe since 2016 for the treatment of iron deficiency anemia (IDA), initially in patients with inflammatory bowel disease (IBD). The Feraccru AEGIS-CKD study is a pivotal Phase III trial with a primary endpoint evaluating haemoglobin response to Feraccru (ferric maltol, 30mg twice daily) compared to placebo in the treatment of IDA in patients with chronic kidney disease (CKD).

Top-line data is based on the 16-week primary endpoint, with 168 subjects enrolled in 30 renal centres across the US. Initial clinical trial results: Feraccru failed to meet the study�s primary endpoint of demonstrating a statistical difference in change of haemoglobin from baseline compared to placebo at 16 weeks (0.45 v 0.15 g/dL, p=0.1686). The response at 8 weeks demonstrated separation of the treatment arms (0.53 v 0.0 g/dL), which was not sustained to week 16. Patient drop-out rate was low over 16 weeks and similar in both arms- 10 (9%) in the Feraccru arm v 7 (12.5%) placebo, reconfirming the strong tolerability profile of Feraccru.