BioCentury
ARTICLE | Clinical News

Simponi meets Phase III UC endpoint

May 21, 2012 11:34 PM UTC

Johnson & Johnson (NYSE:JNJ) said induction therapy with low- and high-dose Simponi golimumab each met the primary endpoint of a greater proportion of patients achieving a clinical response at week six vs. placebo in the Phase III PURSUIT trial to treat ulcerative colitis (51.8% and 55%, respectively, vs. 29.7%, p<0.0001 for both). Both doses of Simponi also met the secondary endpoints of a greater proportion of patients achieving clinical remission and mucosal healing vs. placebo. The double-blind, international trial enrolled 774 patients with moderately to severely active UC who had failed to respond to or tolerate treatment with 6-mercaptopurine, azathioprine, corticosteroids and/or 5-aminosalicylate, or were corticosteroid dependent. ...