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ARTICLE | Clinical News

InDex's Kappaproct misses primary endpoint in UC trial

June 27, 2014 11:50 PM UTC

InDex Pharmaceuticals AB (Stockholm, Sweden) said Kappaproct as an add-on to standard therapy missed the primary endpoint of a greater proportion of patients achieving clinical remission at week 12 vs. placebo as an add-on in the 131-patient Phase III COLLECT trial to treat chronic, active, treatment-refractory ulcerative colitis (UC). Clinical remission was defined as a Clinical Activity Index ( CAI) score of four points or less. 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 at weeks four and eight and registration remission at week four vs. placebo. Kappaproct also met the secondary endpoint of improving the rate of colectomy at week 22 vs. placebo. Symptomatic remission was defined as no blood in stool and less than 35 weekly stools. Registration remission was defined as a CAI score of four points or less and an endoscopic Mayo score of 0 or 1 point. ...