13th Sep 2018 11:51
LONDON (Alliance News) - Shield Therapeutics PLC said on Thursday it has completed recruitment of patients for the AEGIS-H2H Phase 3b study of oral Feraccru in subjects suffering from inflammatory bowel disease and iron deficiency anemia.
The trial will compare the change in haemoglobin from baseline at 12 weeks after taking 30 milligrams of Feraccru twice a day for 12 weeks against intravenous ferric carboxymaltose dosed in line with its approved regimen.
The primary endpoint is non-inferiority of haemoglobin response at 12 weeks with preliminary results expected in the first quarter of 2019.
Feraccru is a novel iron therapy approved and marketed in Europe for the treatment of iron deficiency in adults.
"The treatment of people living with IBD who develop IDA has increasingly been focused on intermittent IV infusions of iron due to intolerance or lack of efficacy of oral iron salts. The completion of recruitment into this study is an important step in confirming the potential of Feraccru to be an alternative to IV iron in these patients," said Chief Medical Officer Mark Sampson.
Shares in Shield Therapeutics were down 3.2% at 30.00 pence on Thursday.
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