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Positive Phase 3 data for new ferric formulation
LONDON—Today Shield Therapeutics plc announced positive results from the open-label extension phase of the AEGIS-CKD pivotal study of Feraccru, a novel oral ferric iron therapy that 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). Feraccru is a stable, non-salt formulation of ferric iron, which has a differentiated mechanism of action compared to salt-based oral iron therapies.
The Feraccru AEGIS-CKD study was a pivotal Phase 3 randomized, placebo-controlled, double-blind trial in chronic kidney disease (CKD) patients with IDA, which demonstrated superiority of Feraccru when the change in hemoglobin (Hb) from baseline after 16 weeks of treatment with oral Feraccru (30mg twice daily) was compared to placebo. This was followed by a 36-week open-label extension phase during which all subjects were treated with Feraccru. For those patients initially treated with Feraccru, Hb levels were maintained over this 36-week follow-up period and the treatment continued to be well tolerated. Overall, 73.6% of subjects entering the open-label extension period stayed on Feraccru therapy and successfully completed the 52-week study.
“Iron deficiency is a significant and progressive issue in patients with chronic renal disease which has been challenging to treat due to poor compliance with traditional oral iron salts,” said Dr. Mark Sampson, Chief Medical Officer of Shield. “These results suggest that Feraccru offers a well-tolerated and effective treatment option which can benefit patients over the long-term.”
In addition, subjects who switched to Feraccru for the open-label phase showed a similar mean rise in Hb over their first 16 weeks of Feraccru treatment when compared to those initially treated with Feraccru (0.79g/dl v 0.57g/dl). These data further support the company’s hypotheses that Feraccru is consistently well absorbed, and that chronic treatment with Feraccru can maintain Hb levels. As previously shown in patients with IDA associated with IBD, this study in CKD patients demonstrates that Feraccru is also well tolerated in a group of patients whose IDA is caused by a very different primary disease.
“Such positive long-term treatment data for Feraccru in complex patients with chronic diseases like CKD provides a very promising signal for the future commercial success of Feraccru. Having previously seen similar positive long-term effects in IBD patients with IDA, this further clinical trial data provides additional evidence that Feraccru is well-tolerated by a majority of treated patients and is effective at correcting IDA. We hope that this positive data provides the necessary evidence to both prescribers and patients with iron deficiency with or without anaemia that Feraccru offers a simple to administer, well tolerated and efficacious treatment alternative that does not require hospital-based administration,” added Carl Sterritt, CEO and founder of Shield.