Global biopharmaceutical company UCB has announced positive results from its Phase IIb open-label extension study of epratuzumab, which is being developed to treat systemic lupus erythematosus (SLE) or lupus.
The study is an extension of the 12-week, double-blind, placebo-controlled EMBLEM study, and is designed to assess safety over a longer period.
The study focused on the long-term effects of the drug in adult patients with moderate-to-severe SLE, and showed no fresh signals related to safety or tolerability, the primary outcome.
UCB conducted the main EMBLEM study to identify a suitable dosing regimen for epratuzumab to treat lupus, which is a complex and systemic autoimmune disease that can affect various organ systems of the human body, including the skin, joints, lungs, kidneys and blood.
The extension study’s secondary outcome data showed that the epratuzumab’s efficacy, in terms of disease reduction, was maintained for two years when compared to EMBLEM baseline values, and also observed that two years of treatment with the drug helped reduce corticosteroid use in patients receiving >7.5 mg/day.
Cedars-Sinai Medical Center clinical professor of medicine Dr Daniel Wallace said that in the EMBLEM study, a reduction in disease activity was observed in patients treated with epratuzumab.
"This double-blind study had a relatively short 12-week, placebo-controlled, treatment period and it was important to accumulate long-term data on epratuzumab in the treatment of SLE," said Wallace.
"The Phase IIb extension study adds new two year open-label data on epratuzumab to that already available from the 12-week, randomised, controlled study."
The investigational medicine, which is licensed from Immunomedics and due to be approved for the treatment of SLE by any regulatory authority worldwide, is said to be the first CD-22/B-Cell receptor (BCR) targeted monoclonal antibody used in clinical trials to treat SLE.
In the main Phase IIb study, 227 patients with SLE were given either placebo or epratuzumab with a cumulative dose of 200mg, 800mg, 2400mg or 3600mg.
The open-label extension recruited 203 patients from any arm of the EMBELM trial to receive epratuzumab 1200mg at weeks 0 and 2 of 12-week cycles, said the company.
Image: The new open-label extension study helps accumulate long-term data on epratuzumab in the treatment of SLE. Photo: Courtesy of UCB SA.