Lilly's mirikizumab improves clinical remission in Phase II for ulcerative colitis

Eli Lilly and Co. (NYSE:LLY) reported in June that 200 mg IV mirikizumab (LY3074828) met the primary endpoint of improving clinical remission rate at week 12 vs. placebo in a Phase II trial to treat moderate to severe ulcerative colitis (p<0.05). Clinical remission was defined as achieving a Mayo rectal bleeding subscore of 0 points, a stool frequency subscore of 0 or 1 point plus a decrease from baseline of at least 1 point, and an endoscopy subscore of 0 or 1 point.

The double-blind, international trial enrolled about 240 patients who previously failed conventional or biologic therapy to receive placebo or 50, 200 or 600 mg mirikizumab at weeks zero, four and eight. Patients in the low- and mid-dose mirikizumab arms were allowed to received exposure-based increases of the product of up to 600 mg. The dose-adjusted 50 mg and fixed 600 mg dose arms of mirikizumab missed the primary endpoint. Across all three mirikizumab arms, 11.5-22.6% of patients achieved clinical remission at week 12 vs. 4.8% of placebo patients...