Business
AEGIS-H2H study reanalysis
AEGIS-H2H study reanalysis.
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n \n \n RNS Number : 3992V\n Shield Therapeutics PLC\n 06 August 2020\n \n \n \n \n The information contained within this announcement is deemed by the Group to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain\n \n \n \n \n \n Shield Therapeutics plc\n \n \n (\"Shield\" or the \"Group\" or the \"Company\")\n \n \n \n \n \n AEGIS-H2H study reanalysis demonstrates that\n \n \n Feraccru®/Accrufer® is a credible alternative to IV therapy for iron deficiency anaemia\n \n \n \n \n \n \n Feraccru®/Accrufer® corrects anaemia and maintains Hb levels\n \n \n over the long term\n \n \n \n \n \n \n \n \n \n \n London, UK, 6 August 2020: \n \n Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product \n Feraccru\n ®\n /Accrufer\n ® \n (ferric maltol),\n provides the headline results from the reanalysis of the AEGIS-H2H study\n . \n \n \n \n \n \n The AEGIS-H2H study was intended and designed to provide data comparing oral \n Feraccru\n ®\n /Accrufer\n ®\n \n against intravenous (IV) iron therapy from which health economics data and other analysis could be generated. The study was not intended as a registration study and the regulatory status of \n Feraccru\n ®\n /Accrufer\n ®\n is \n unaffected by the study. On 17 March 2020 Shield announced an update and clarification relating to the original results of the AEGIS-H2H study (announced in March 2019) and that the Board had instigated a thorough and complete review into the analysis. This review has now been completed, including an independent statistical review. \n \n \n \n \n \n The Feraccru®/Accrufer® AEGIS-H2H study was a multi-national Phase IIIb randomised study in 250 inflammatory bowel disease (IBD) patients with mild to severe iron deficiency anaemia (IDA) and baseline haemoglobin (Hb) measurements at the start of the study as low as 8.0g/dL. The main objectives of the study were to compare the impact of \n Feraccru\n ®\n /Accrufer\n ®\n \n on Hb levels over 52 weeks with that of Ferinject® (ferric carboxymaltose (FCM)...