June 13, 2008

UCB Reports Initial Clinical Data Provide Encouraging Results

PARIS, FRANCE – UCB announced that data presented Thursday show that epratuzumab treatment demonstrated clinically meaningful improvements in moderate and severe flaring systemic lupus erythematosus (SLE) patients. The data were from the first placebo–controlled studies using epratuzumab in SLE patients and were presented at the annual European Congress of Rheumatology (EULAR).

The clinical studies presented at EULAR showed that flaring SLE patients treated with epratuzumab experienced reduced disease activity and were less reliant on the use of steroids to control the disease than those receiving placebo. The incidence of adverse events was similar for the epratuzumab and placebo groups.

“These initial clinical results for epratuzumab are very encouraging,” commented lead study author Dr Michelle Petri, Director, Lupus Center and Professor of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. “Developing new compounds for SLE patients is critical because currently available treatments, such as immunosuppressants and corticosteroids, often have serious and debilitating side-effects. We look forward to seeing results from other clinical trials involving epratuzumab.”

Epratuzumab is a fully-humanized anti-CD22 compound with the potential to modulate B-cell activity. Although the exact function of CD22 is not fully understood, it is known to be involved in B-cell development, function and survival. B-cells are known to contribute to SLE by producing antibodies against the body’s own tissues, causing the body’s immune system to turn on itself, attacking cells and tissue and resulting in inflammation and tissue damage. SLE is a chronic and potentially fatal autoimmune disease with a variable and unpredictable course. It can affect any part of the body, but most often harms the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system and is characterized by periods of flares, or exacerbations, interspersed with periods of improvement or remission.

In the clinical studies, 90 patients were randomized to receive epratuzumab 360 or 720 mg/m2 infusions at weeks 0, 1, 2 and 3, with subsequent treatment cycles of two infusions one week apart, every 12 weeks, for up to four treatment cycles over a 48-week period. The efficacy endpoints included a reduction in disease activity, as measured by the BILAG* Activity Index, steroid sparing and improvements in both physician and patient global disease activity assessments. Both doses of epratuzumab resulted in clinically meaningful reductions in total BILAG scores versus placebo from week 4 through to week 48 and reduced steroid use. Also, according to physician and patient global assessment scores, more epratuzumab patients showed improvement compared with the placebo group, with a high degree of correlation between the patient and physician global assessments. Additionally, epratuzumab was shown to be well-tolerated in these studies, with a similar safety profile as placebo. The incidence of serious adverse events, adverse events in particular reflecting infections and infusion-related reactions, were similar across active and placebo treatments.

UCB has initiated a new Phase IIb clincal study program for epratuzumab, which consists of two studies. The primary objective of the phase IIb program is to assess the dose response and the dose frequency for epratuzumab. Further information on the study can be found at Clinicaltrials.gov.

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