Certolizumab Shows Significant Benefit in Moderate to Severe Crohns Disease
Jul 27, 2005 - 2:10:38 PM
UCB today announced significant positive results for the two pivotal phase III trials (PRECISE 1 and 2) of CIMZIATM (certolizumab pegol, CDP870) in the induction and maintenance of clinical response in moderate to severe active Crohns disease. The PRECiSE trials assessed the safety and efficacy of CIMZIA compared to placebo over a 26 week period, in a total of 1330 patients with active Crohns disease.
The primary endpoints in both the PRECiSE 1 and PRECiSE 2 trials were met with statistical significance, irrespective of C-reactive protein (CRP, a marker of inflammation) status or prior exposure to anti-TNF therapy. In addition, data from both trials suggest CIMZIATM is well-tolerated.
CIMZIATM is therefore the first subcutaneously-administered anti-TNF biologic to successfully meet the primary endpoints in a phase III clinical trial programme in Crohn's disease.
A regulatory submission for CIMZIATM in the treatment of Crohns disease is scheduled to be submitted in both the US and Europe within the next six to nine months.
These results are highly encouraging, showing a significant potential to address the considerable unmet medical need in the treatment of Crohns disease and to bring new hope to the hundreds of thousands of patients affected by this debilitating disease, commented Prof. William Sandborn, Mayo Clinic College of Medicine, Rochester, Minnesota, USA, principal investigator on the PRECiSE 1 trial. The results from the PRECiSE trials suggest CIMZIA to be highly effective at reducing the symptoms associated with Crohns disease.
Dr. Stefan Schreiber, principal investigator on the PRECiSE 2 trial, and Professor of Medicine and Gastroenterology at the Christian-Albrechts University, Kiel, Germany, further highlighted the advantages of CIMZIATM in offering highly convenient dosing with a patient-friendly, subcutaneous route of administration, having the potential to improve the long-term management of this lifelong disease.
Data from PRECiSE 1 and 2 will be presented in more detail at the major forthcoming gastroenterology congresses.
The findings of the PRECiSE trials are consistent with our vision of changing patients lives for the better, said Roch Doliveux, CEO, UCB. With the robust clinical results and its subcutaneous administration, CIMZIATM has the potential to have a significant impact on the treatment of Crohns disease.
About Crohns disease
Crohns disease is a chronic inflammatory disease of the gastrointestinal tract with the disease typically localized in the terminal part of the ileum and right colon. Crohns disease affects almost 1 million patients worldwide, with the disease typically appearing early in life.
CIMZIATM is a unique anti-TNF biologic. CIMZIATM is a PEGylated Fab fragment of a humanised anti-TNF ? monoclonal antibody, with high affinity for both soluble and membrane-bound TNF ?. CIMZIATM is currently the subject of phase III clinical trials in both Crohns disease and rheumatoid arthritis.
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