Data from Pharmawand - Curated by EPG Health - Date added 24 October 2019
Shield Therapeutics plc announces that results from its multicentre phase IIIb, open-label randomised controlled trial presented at the 27th United European Gastroenterology Week (UEG). Headline data were previously announced in March 2019.
The study was conducted unblinded and with a non-inferiority design in which 250 subjects were recruited to compare oral Feraccru /Accrufer 30mg BD for 52 weeks with IV ferric carboxymaltose administered in line with the licensed dosing schedule. The primary endpoint was the response rate (defined as a rise in haemoglobin (Hb) greater than 2g/dl or attainment of a normal Hb level) at 12 weeks. The study also allowed evaluation of daily dosing with oral Feraccru/Accrufer in maintaining iron status and preventing recurrence of iron deficiency anaemia.
Key findings: Response rate at 12 weeks was 74% for oral Feraccru /Accrufe and 83% for IV ferric carboxymaltose. The 9% difference was well within the pre-specified non-inferiority margin of 20% (p=0.017) Recurrence of iron deficiency anaemia occurred at least once in approximately 39% (49) of the subjects in the IV arm of the study following the initial treatment with IV ferric carboxymaltose, requiring a total of 69 additional IV iron infusions to be administered. Feraccru /Accrufer was generally well tolerated over 52 weeks of treatment with a side effect profile consistent to that seen in previous placebo-controlled studies.
Dr Mark Sampson, Chief Medical Officer of Shield, said: “This data shows not only that physiological oral iron replacement with Feraccru can produce a similar response rate to IV iron at 12 weeks, but that Feraccru is effective and well tolerated over 52 weeks, even in patients who have been unable to tolerate oral iron salts previously.”
Dr Stefanie Howaldt, specialist in internal medicine at the MVZ-Immunology Clinic in Hamburg and principal investigator in the study said “This data shows that not only is Feraccru a real oral alternative to IV iron for these patients with iron deficiency anaemia, but that it can also prevent the need for repeated IV infusions.”