Shield's ST10 meets in Phase III anemia trial in IBD patients

Shield Therapeutics AG (Wollerau, Switzerland) said twice-daily oral ST10 met the primary endpoint of improving mean hemoglobin levels from baseline to week 12 vs. placebo in a Phase III trial to treat iron deficiency anemia associated with inflammatory bowel disease (IBD). ST10 led to a mean improvement in hemoglobin levels of 2.3 g/dL over placebo (p<0.0001). ST10 also met the secondary endpoints of improving mean hemoglobin levels from baseline to week four and to week eight vs. placebo (p<0.0001 for both). The double-blind, international trial enrolled 128 patients with iron deficiency anemia secondary to ulcerative colitis (UC) or Crohn's disease (CD) who had previously failed therapy with oral ferrous products due to intolerance and/or inadequate therapeutic benefit. Data from a 12-month, open-label extension trial are expected this year. ...