Kappaproct: Phase III data
Top-line data from the double-blind, European Phase III COLLECT trial in 131 patients with chronic, active, treatment-refractory moderate to severe UC showed that 2 rectal doses of 30 mg Kappaproct given 4 weeks apart as an add-on to standard therapy missed the primary endpoint of a greater proportion of patients achieving clinical remission, defined as a CAI score of <=4 points, at week 12 vs. placebo as an add-on to standard therapy. InDex said there was an unexpectedly high remission rate in the placebo group. Kappaproct met the secondary endpoints of a greater proportion of patients achieving symptomatic remission, defined as no blood in stool and <35 weekly stools, at weeks 4 and 8 and a greater proportion of patients achieving registration remission, defined as a CAI score of <=4 points plus an endoscopic Mayo score of 0 or 1 point, at week 4 vs. placebo. Additionally, Kappaproct met the secondary endpoint of improving the rate of colectomy at week 22 vs. placebo. Kappaproct was well tolerated. ...