Shield Therapeutics’ Feraccru (ferric maltol) oral ferric iron therapy has failed to meet the primary efficacy endpoint in the AEGIS-CKD phase III study for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
Feraccru is a stable, non-salt and formulation of ferric iron, which includes differentiated mechanism of action compared to salt-based oral iron therapies.
The phase III trial with a primary endpoint assessed haemoglobin response to Feraccru compared against placebo in the treatment of IDA in patients with chronic kidney disease (CKD).
The company recruited 168 subjects in 30 renal centres across the US, and top-line date is based on the 16-week primary endpoint.
According to the company, Feraccru failed to meet the study's primary endpoint of showing a statistical difference in change of haemoglobin from baseline compared to placebo at 16 weeks.
Feraccru oral ferric iron therapy was approved and commercialised in Europe to treat IDA in patients with inflammatory bowel disease (IBD).
Shield Therapeutics CEO Carl Sterritt said: "Feraccru has previously demonstrated positive efficacy and safety in IBD patients, which led to it being approved in Europe where it continues to gain commercial traction.
“We now await the full dataset in order to fully understand the study's outcome and define the next steps in our strategy. Concurrently, we will focus on interacting with EMA on the label expansion application, on concluding the AEGIS-H2H study as expeditiously as possible and on taking actions to extend the current cash runway beyond the end of Q2 2018."
The firm also designed AEGIS-H2H Phase 3b study to compare the efficacy and safety of Feraccru to the market-leading latest generation form of IV iron Ferinject/Injectafer (ferric carboxymaltose).
Shield is planning to reveal the results of the trial n the second half of this year.