Feraccru non-inferior to IV iron therapy in treating iron deficiency anaemia.

Shield Therapeutics got positive results from the AEGIS-H2H clinical trial which compared Feraccru (ferric maltol) to Ferinject (ferric carboxymaltose (FCM)), as Feraccru has demonstrated it is non-inferior to IV iron therapy in treating iron deficiency anaemia.

Feraccru is approved and marketed in the European Union for the treatment of iron deficiency (ID) in adults and in Switzerland for the treatment of iron deficiency anaemia (IDA) in adults with inflammatory bowel disease (IBD).  A New Drug Application in the USA is being reviewed by the FDA with a PDUFA date of July 27, 2019, the company said in a statement Monday.

Dr Mark Sampson, Chief Medical Officer of Shield, said: “In a challenging phase IIIb clinical study, in which Feraccru has been tested against Ferinject, the standard of care for patients who cannot tolerate or are unwilling to take salt-based oral iron therapies, orally delivered Feraccru has demonstrated it is non-inferior to IV iron therapy in treating iron deficiency anaemia.

These data enhance the treatment options for such patients as they demonstrate that Feraccru offers a well-tolerated and effective therapy, which can benefit patients in both the short and long term. I would like to thank the patients, healthcare professionals, our CRO partner Clinipace and Shield’s clinical development team both past and present for the dedication, commitment and professionalism shown in completing this complicated and challenging study and achieving this excellent result.”

Carl Sterritt, CEO and Founder of Shield, said: “We are delighted that Feraccru has once again performed so well in a phase III clinical trial, this time delivering a major achievement in showing itself to be non-inferior to IV iron therapy, further reinforcing the value of Feraccru. We are particularly pleased to see such a clinically relevant response to Feraccru throughout the pre-defined assessment timepoints in this complex study, having previously seen very similar long-term benefits in IBD patients with IDA in the AEGIS-IBD study. These data provide yet further evidence that Feraccru is well-tolerated by a majority of treated patients and is effective at correcting both their iron deficiency and anaemia. 

“We look forward to presentations of the AEGIS-H2H data at upcoming scientific meetings and working with our commercial partners to ensure prescribers, payors, experts responsible for the publication of treatment guidelines and the many eligible patients are aware that Feraccru® offers a simple to administer, well tolerated and efficacious oral treatment alternative to IV iron therapy, without the need for hospital-based administration.”