LONDON (ShareCast) - (ShareCast News) - Speciality secondary care-focussed pharmaceutical company Shield Therapeutics announced the completion of enrollment of the pivotal Phase 3 AEGIS-CKD study of its European-marketed product, Feraccru, on Tuesday.
The AIM-traded firm was anticipating top-line data, based on the 16-week primary endpoint, early in the first quarter of 2018, with subjects enrolled in 30 renal centres across the US.

A positive outcome from the study would enable initiation of the regulatory filing with the US Federal Drug Administration, that could lead to the commercialisation of Feraccru in the US and increase the target population for Feraccru from around 330,000 inflammatory bowel disease (IBD) patients with iron deficiency anaemia (IDA) in Europe, to around 2.6m patients with IDA related to both IBD and CKD in Europe and the US, Shield's board explained.

The study was evaluating Feraccru (ferric maltol, 30mg bd) compared to placebo in the treatment of IDA in patients with non-dialysis chronic kidney disease (CKD).

Shield said Feraccru was currently approved in Europe for the treatment of IDA in adults with IBD, and it recently filed for approval of an expanded label for Feraccru in Europe.

"We are pleased to reach this important recruitment milestone," said Shield's chief medical officer Dr Mark Sampson.

"Many CKD patients struggle to tolerate currently available oral iron preparations, resulting in poor control of their IDA."

Dr Sampson said the company was looking 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."

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