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Top-line results from Feraccru Phase III study
Top-line results from Feraccru Phase III study.
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 8549D Shield Therapeutics PLC 05 February 2018 \n\nThis announcement contains inside information for the purposes of Article 7 of Regulation 596/2014. \n \nShield Therapeutics plc\n(\"Shield\" or the \"Group\")\nShield reports top-line results from pivotal Phase III study of Feraccru® (Ferric Maltol) in the treatment of IDA in patients with CKD\n \n- Primary efficacy endpoint not achieved\n- Tolerability profile of Feraccru reconfirmed\n- A review of the full dataset will be conducted to better understand the result\n- Feraccru remains commercially available for IBD patients with IDA through Shield and its commercial partners in Europe and other ongoing clinical studies will continue\n \nLondon, UK, 5 February 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, with an initial focus on addressing anaemia associated with renal and gastrointestinal disorders, today 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).\n \nThe 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. \n \nInitial clinical trial results:\nFeraccru 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). \n \nThe response at 8 weeks demonstrated separation of the treatment arms (0.53 v 0.0 g/dL), which was not sustained to week 16. \n \nPatient 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...