UCB and Immunomedics announce positive results for epratuzumab phase IIb study in systemic lupus erythematosus (SLE)
Data from phase IIb dose and regimen-ranging study demonstrate clinically meaningful treatment effect
UCB and Immunomedics announced top-line results from UCB's Phase IIb clinical study comparing epratuzumab to placebo in patients with systemic lupus erythematosus (SLE, also commonly known as lupus). The data from the 12-week dose and regimen-ranging study demonstrated clinical meaningful treatment effect of epratuzumab over placebo in SLE patients. The 227 patients in this study had moderately (30%) to severely (70%) active disease in multiple organ systems.
The primary efficacy measure was a combined index endpoint, which included several indices of SLE disease activity, primarily emphasizing BILAG measured improvement. Treatment advantage of epratuzumab over placebo reached 24.9% at week 12.
"Epratuzumab is the most advanced pipeline program in UCB's immunology disease portfolio and the positive results are significant for UCB as we continue to move our antibody based programs ahead", said Roch Doliveux, Chief Executive Officer of UCB.
Epratuzumab, developed by Immunomedics and licensed to UCB for all autoimmune disease indications in 2006, is a humanised anti-CD22 monoclonal antibody with the potential to modulate B cell activity. Although the exact role of CD22 is not fully understood, it is considered to be a negative regulator of B cell function. B cells are known to contribute to SLE by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself, resulting in inflammation and tissue damage.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous