ARTICLE | Clinical News
Shield falls on Phase III Feraccru miss
February 5, 2018 9:55 PM UTC
Shield Therapeutics plc (LSE:STX) fell 65p (58%) to 47.50p on Monday after reporting that Feraccru ferric maltol missed the primary endpoint in the U.S. Phase III AEGIS-CKD trial to treat iron deficiency anemia (IDA) in patients with non-dialysis-dependent chronic kidney disease (CKD).
On the 168-patient trial's primary endpoint, twice-daily oral 30 mg Feraccru failed to significantly improve hemoglobin levels from baseline to week 16 vs. placebo (0.45 vs. 0.15 g/dL, p=0.1686). Shield said it will determine next steps, including its plans for an NDA submission to FDA, after it has analyzed the full dataset from AEGIS-CKD. Full data are expected by April...
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