FDAnews
www.fdanews.com/articles/100639-trial-results-for-exelixis-8217-xl784-presented

Trial Results for Exelixis’ XL784 Presented

November 5, 2007

Exelixis presented data from its Phase II trial of XL784 in subjects with albuminuria due to diabetic nephropathy.

XL784 is a small molecule inhibitor of two metalloprotease enzymes that may play a role in the pathogenesis of diabetic nephropathy and renal fibrosis. The trial did not meet its primary endpoint, Exelixis said.

This randomized, double-blind, placebo-controlled study enrolled 125 subjects. XL784 (200 mg once daily for 12 weeks) was compared with placebo in subjects being treated concurrently with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker.

XL784 was generally well tolerated, with fewer subjects reporting adverse events in the XL784 group (77 percent) than in the placebo group (85 percent).