Vercirnon: Phase III halted

GlaxoSmithKline halted its Phase III program for vercirnon in CD after data from the double-blind, international Phase III SHIELD-1 trial in 608 patients with moderately to severely active CD showed that vercirnon missed the primary endpoint of improving clinical response, defined as a reduction in CDAI score of >=100 points from baseline, and the secondary endpoint of improving clinical remission, defined as a CDAI score of <150 points, at week 12 vs. placebo. Additionally, GSK said that while the rates of serious adverse events and withdrawals due to adverse events were similar among treatment groups, there was a trend for dose-dependent increases in overall adverse event rates with vercirnon. The trial enrolled patients who were not adequately controlled with conventional therapy, including patients who did not respond to tumor necrosis factor (TNF) alpha antagonists. Patients received placebo or 500 mg vercirnon once or twice daily. GSK declined to disclose details but said it will submit full data for presentation at a scientific meeting and for publication in a journal. ChemoCentryx said it does not yet have access to the SHIELD-1 data, but does "not believe there is evidence that CCR9 is anything but a good target." ...