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ARTICLE | Clinical News

Shield's oral Feraccru non-inferior to IV Injectafer in Phase IIIb

March 15, 2019 5:34 PM UTC

Shield said oral Feraccru ferric maltol met the primary endpoint of non-inferiority to IV Injectafer ferric carboxymaltose in the Phase IIIb AEGIS-H2H trial to treat iron deficiency anemia in adults with inflammatory bowel disease (IBD).

On the 242-patient trial's primary endpoint, Shield Therapeutics plc (LSE:STX) said twice-daily Feraccru led to a hemoglobin response rate, defined as normalization of hemoglobin or a >2 g/dL increase in hemoglobin from baseline, that was within 9% of the response rate for Injectafer at week 12 (p=0.022 for non-inferiority). The non-inferiority margin was 20%...