Shield Therapeutics reported the results from its AEGIS-CKD pivotal Phase III study of Feraccru, 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.
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.”