The AEGIS-CKD study of Feraccru was a phase 3 randomized, placebo-controlled, double-blind trial. Compared to placebo, Shield Therapeutics’ ferric iron therapy showed superiority in changing haemoglobin (Hb) levels from baseline after 16 weeks of treatment, twice a day in 30mg dosage.
After the 16-week treatment, a 36-week open-label extension phase was taken up in which all patients treated with Shield Therapeutics’ lead candidate had their Hb levels maintained.
Additionally, patients who were changed to Feraccru treatment for the open-label phase demonstrated a similar mean rise in Hb levels over their first 16 weeks when compared to those who were initially put on the same therapy.
Shield Therapeutics said that the latest data support its hypotheses that the company’s ferric iron therapy is well absorbed on a consistent basis and that chronic treatment with it can sustain Hb levels.
Feraccru is already approved and marketed in the European Union for the treatment of iron deficiency in adults. In Switzerland, the ferric iron therapy was approved for the treatment of IDA in adults with inflammatory bowel disease (IBD).
Shield Therapeutics CEO and founder Carl Sterritt said: “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.”
Feraccru is a stable, non-salt and formulation of ferric iron, which is said to have differentiated mechanism of action compared to salt-based oral iron therapies.
In October 2018, Shield Therapeutics submitted a new drug application (NDA) with the US Food and Drug Administration (FDA) for the ferric iron therapy for the treatment of iron deficiency.