Shield reports top-line results from pivotal Phase III study of Feraccru
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.
Carl Sterritt, Chief Executive Officer of Shield Therapeutics, said: “We are surprised and disappointed by these top-line findings. Feraccru has previously demonstrated positive efficacy and safety in IBD patients, which led to it being approved in Europe where it continues to gain commercial traction. We now await the full dataset in order to fully understand the study’s outcome and define the next steps in our strategy. Concurrently, we will focus on interacting with EMA on the label expansion application, on concluding the AEGIS-H2H study as expeditiously as possible and on taking actions to extend the current cash runway beyond the end of Q2 2018.”