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Completion of patient enrolment in Phase 3 study
Completion of patient enrolment in Phase 3 study.
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 1132T Shield Therapeutics PLC 10 October 2017 \n\n \nShield Therapeutics plc\n(\"Shield\" or the \"Group\")\n \nCompletion of patient enrolment in pivotal AEGIS-CKD Phase 3 study \n \nTop line data anticipated early in the first quarter of 2018 \n \nLondon, UK, 10 October 2017: Shield Therapeutics plc (LSE:STX), a specialty pharmaceutical company focused on secondary care, today announces the completion of enrollment of the pivotal Phase 3 AEGIS-CKD study 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. \n \nA 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.\n \nThe 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.\n \nDr 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.\"\n \n- Ends -\n \nFor further information please contact:\n \nShield Therapeutics plc  ...