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Shield Therapeutics tumbles after anaemia treatment falls short at trials
Shares in AIM-listed specialist pharmaceutical company Shield Therapeutics were in free fall on Monday after it revealed that while top-line results from its pivotal phase three study into its drug Feraccru reconfirmed its tolerability profile, it was unable to achieve its primary efficacy endpoint.
Results from an AEGIS-CKD study into Feraccru, an oral ferric iron therapy used for the treatment of iron deficiency anaemia, initially in patients with inflammatory bowel disease, saw the drug fail to meet the study's primary endpoint of demonstrating a statistical difference in change of haemoglobin from baseline when measured against a placebo alternative.
Chief executive officer 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."
At 1000 GMT, the shares were down 51.1% to 55.00p.
Results from an AEGIS-CKD study into Feraccru, an oral ferric iron therapy used for the treatment of iron deficiency anaemia, initially in patients with inflammatory bowel disease, saw the drug fail to meet the study's primary endpoint of demonstrating a statistical difference in change of haemoglobin from baseline when measured against a placebo alternative.
Chief executive officer 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."
At 1000 GMT, the shares were down 51.1% to 55.00p.
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