UCB, a Belgium-based bio pharmaceutical firm, and Immunomedics, a US-based developer of monoclonal and antibody-based products, have released top-line results from UCB’s phase IIb clinical study. The trial was directed at comparing epratuzumab to placebo in patients with systemic lupus erythematosus (SLE, also commonly known as lupus).
According to Immunomedics, 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 moderate (30%) to severe (70%) active disease in multiple organ systems.
Immunomedics said that 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.
Immunomedics claims that Epratuzumab, developed by Immunomedics and licensed to UCB for all autoimmune disease indications in 2006, is a humanized anti-CD22 monoclonal antibody with the potential to modulate B-cell activity.
Roch Doliveux, CEO of UCB, said: 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. These results may provide new hope for the hundreds of thousands of people around the world living with SLE as no new treatment was approved for this life altering disease for over five decades.
Cynthia Sullivan, president and CEO of Immunomedics, said: We are delighted that this randomized, placebo-controlled, study conducted by UCB demonstrates the activity of epratuzumab in SLE, which has proven to be difficult to treat with currently available drugs. Epratuzumab is a unique anti-B-cell therapeutic, because of its ability to modulate B-cell function without depleting a large portion of these lymphocytes.