UCB’s experimental drug Cimzia is effective and well tolerated in treating Crohn’s disease, a chronic inflammatory disorder of the digestive tract, researchers said on Tuesday.
The Belgian drugmaker said it planned to file the drug for regulatory approval in both the United States and Europe during the first quarter of 2006.
The antibody treatment was originally developed by British biotechnology company Celltech, which UCB acquired last year.
Phase III trial results presented at the United European Gastroenterology Week meeting in Copenhagen showed 62.8 percent of patients on Cimzia maintained an overall clinical response after six months of treatment, against 36.2 percent on a placebo.
Cimzia belongs to a class of drugs known as anti-TNF agents that work by blocking a protein called tumor necrosis factor. They were originally developed to fight rheumatoid arthritis but have more recently been used to tackle a range of other inflammatory diseases, including Crohn’s.
Professor Stefan Schreiber of Christian-Albrechts University, Kiel, Germany, said Cimzia had shown the efficacy expected of an anti-TNF agent but was well tolerated and had the advantage of being given as a simple under-the-skin injection.
Olav Hellebo, head of inflammation operations at UCB, said the robust results were “highly encouraging” and suggested Cimzia offered hope to thousands of Crohn’s disease patients.
Johnson & Johnson and Schering-Plough Corp.’s Remicade is currently the only marketed anti-TNF drug for moderate-to-severe Crohn’s disease.
