UCB’s new lupus treatment promising
pharmafile | June 17, 2010 | News story | Research and Development | Benlysta, Lupus, UCB, epratuzumab
A new monoclonal antibody treatment for lupus has shown promise in phase II trials, according to UCB.
The biopharmaceutical company and its development partner Immunomedics say new data shows epratuzumab helps to cut inflammation and tissue damage caused by the autonimmune disease.
The disease can occur in any part of the body, but the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system are most frequently affected.
It has been 50 years since any new treatment has emerged for the condition, but now a handful of companies are developing new drugs for the condition. The most notable rivals to UCB are GSK and its partner Human Genome Sciences, who have just submitted a marketing application for their product Benlysta.
UCB’s study EMBLEM was a 12-week phase IIb, placebo-controlled study to define a dose and regimen in patients with moderate to severe active systemic lupus erythematosus (SLE).
The trial measured patient response against BILAG, British Isles Lupus Assessment Group, a comprehensive scoring system for assessing SLE disease activity.
“We are very encouraged by the findings of this new study which demonstrate that in a patient population with predominantly severe disease activity, epratuzumab is improving patients’ health as quickly as week 12, with the emergence of improvements as early as week 8,” commented lead investigator Daniel Wallace, clinical professor of medicine, David Geffen School of Medicine, UCLA.
He added, “In a short study, such as this one, seeing this level of patient improvement so rapidly is a hopeful sign of the drug’s potential to become an effective new treatment option.”
In total, 74 patients took part in the trial and were randomised to one of six intravenous regimens. Response rates to the drug only reached statistical significance in one of the regimens (600mg weekly group) and the combined group of all patients, which showed twice the level of response compared to placebo.
UCB says clinical impact was particularly prominent in cardiorespiratory and neuropsychiatric systems, in which symptom improvements are often difficult to achieve.
Professor Kenneth Kalunian, associate director of the Center for Innovative Therapy, Allergy and Immunology in the School of Medicine at UCSD, said the results were ‘promising’.
“In lupus, a disease that has not seen a new drug approved in more than fifty years, epratuzumab shows encouraging signs of being able to improve patient lives in this devastating and life altering disease,” he said.
Andrew McConaghie
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