Positive Ph II data for UCB/Immunomedics epratuzumab

Belgian drugmaker UCB and US firm Immunomedics announced today 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 of UCB. "These results may provide new hope for the hundreds of thousands of people around the world living with SLE as no new treatment has been approved for this life altering disease for over five decades," he added.

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.  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.

Analysts at Jefferies called the results for epratuzumab encouraging, but said they are retaining their estimate of $150 million in peak sales and 30% likelihood of success until full data from the Phase IIb study are released, reports CNBC.