Belgian drugmaker UCB says that new pivotal Phase III trial data presented at the Digestive Disease Week 2006 conference, held in Los Angeles, USA, demonstrate that a significantly greater proportion of moderate-to-severe Crohn's disease patients achieved clinical response versus placebo with subcutaneous once-monthly Cimzia (certolizumab pegol, CDP870), its new type of anti-tumor necrosis factor therapy.
According to the Brussels-based firm, the results from the Phase III PRECiSE 1 evaluation show significant clinical effectiveness and tolerability. PRECiSE 1 is the first reported Phase III trial of an anti-TNF in Crohn's extending beyond four weeks, in which eligible patients were randomized at study baseline without pre-selection of responders. The overall PRECiSE clinical trial program anchored UCB's recent regulatory submission packages in both the USA and Europe and represents the largest and broadest patient clinical trial database for a biological treatment ofthis inflammatory bowel disorder.
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