Business
Update on the AEGIS-CKD study
Update on the AEGIS-CKD study.
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 9158H Shield Therapeutics PLC 16 March 2018 \n\nShield Therapeutics plc\n(\"Shield\" or the \"Company\")\n \nUpdate on the AEGIS-CKD study \n \nLondon, UK, 16 March 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company with an initial focus on addressing iron deficiency, announces an update following detailed analyses of the data from the double-blind period of the AEGIS-CKD study, which it has presented to the FDA in a previously scheduled pre-NDA meeting.\n \nFollowing a review of all enrolled subjects who completed the initial 16-week placebo-controlled portion of the study, a small number of patients in both treatment arms were identified as experiencing pre-specified events that could have led to withdrawal but, as permitted in the study protocol, with Investigator discretion they remained in the study. The Company believes the inclusion, post the confounding events, of data from these patients could have significantly impacted the haematology-focused primary endpoint of the pivotal study. Consequently, further analyses of the data have been conducted using an amended statistical analysis plan that removed the confounding data.\n \nAs a result of these revised analyses, patients treated with Feraccru demonstrated a statistically significant response (p=0.0149) in haemoglobin levels after 16 weeks of treatment compared to placebo (difference 0.52g/dl (CI 0.102, 0.930) and statistically significant results were achieved across a range of secondary iron parameters (TSAT, Ferritin levels, serum iron levels). Whilst the Company believes there is a clear and robust rationale for the analyses of the dataset as outlined, there can be no certainty that the FDA will accept the approach taken. Details of the outcome of the discussion with the FDA are therefore uncertain and clarity on such matters will be communicated to the market as soon as it is available.\n \nCarl Sterritt, Chief Executive Officer of Shield Therapeutics, said: \"I am reassured that we have rapidly been able to understand what we believe occurred in the study to produce the initial topline result. This has enabled us to take appropriate and well-controlled steps to prepare a data package that underpinned a constructive pre-NDA meeting with the FDA. The...