Shield Therapeutics has reported negative results from its pivotal Phase III study of Feraccru in comparison with placebo in the treatment of iron-deficiency anaemia (IDA) in patients with chronic kidney disease (CKD), after failing to meet the study’s primary endpoint.
The Feraccru AEGIS-CKD trial’s primary endpoint includes evaluation of haemoglobin response to 30mg twice-daily dose of Feraccru compared to placebo in the treatment of IDA in patients with CKD.
Top-line data of the study is based on a 16-week primary endpoint.
However, the trial saw a low rate of patient drop-out over 16 weeks and in both arms, reconfirming the strong tolerability profile of Feraccru.
The trial included 168 subjects in 30 renal centres across the US.
Shield Therapeutics CEO Carl Sterritt said: “We are surprised and disappointed by these top-line findings. 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.”
Shield further noted that the outcome of the Feraccru AEGIS-CKD study will not affect its current status and it will continue to be commercially available for IBD patients with IDA across Europe.
Feraccru is a new, stable, non-salt, oral formulation of ferric iron, which features a separate mechanism of action compared to salt-based oral iron therapies.