Shield Therapeutics has completed enrollment of the Phase 3 AEGIS-CKD clinical trial of its European-marketed product, Feraccru.
Top-line data, based on the 16-week primary endpoint, is anticipated early in the first quarter of 2018. Subjects were enrolled in 30 renal centres across the USA.
A positive outcome from this study will enable initiation of the regulatory filing with the US FDA that could lead to the commercialisation of Feraccru in the US and increase the target population for Feraccru from c. 330,000 Inflammatory Bowel Disease (IBD) patients with Iron Deficiency Anaemia (IDA) in Europe to c. 2.6m patients with IDA related to both IBD and CKD in Europe and the USA.
The study is evaluating Feraccru (ferric maltol, 30mg bd) compared to placebo in the treatment of IDA in patients with non-dialysis Chronic Kidney Disease (CKD).
Feraccru is currently approved in Europe for the treatment of IDA in adults with IBD. Shield recently filed for approval of an expanded label for Feraccru in Europe.
Dr Mark Sampson, Chief Medical Officer of Shield Therapeutics, commented: "We are pleased to reach this important recruitment milestone. Many CKD patients struggle to tolerate currently available oral iron preparations, resulting in poor control of their IDA.
"We look forward to the data early in the first quarter of 2018 and to taking the next steps to make Feraccru available to as many patients as quickly as possible. I would like to thank the patients for their willingness to participate, as well as the clinicians and colleagues who have worked so diligently on this programme."