UCB lupus candidate shows disease benefits
pharmafile | November 11, 2010 | News story | | Benlysta, Lupus, UCB, epratuzumab, monoclonal antibody, systemic lupus erythematosus
A new monoclonal antibody targeting the autoimmune disease lupus is continuing to show a positive effect on sufferers, its manufacturer UCB says.
No new treatment has emerged for 50 years, but the phase IIb study EMBLEM showed certain doses of UCB’s epratuzumab reduce disease activity in adult patients.
The drug is aimed at moderate to severe active systemic lupus erythematosus (SLE), a chronic inflammatory disease of the body’s connective tissue.
“While medical advances have improved the lives and survival of people with lupus, effective therapeutic options remain limited,” said lead study investigator Daniel Wallace of the David Geffen School of Medicine at UCLA.
Epratuzumab helps to cut the inflammation and tissue damage caused by SLE, which can occur in any part of the body.
The heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system are most frequently affected.
Reduced disease activity was observed as early as week eight, with further improvements to week 12, according to UCB in data presented to the 74th Annual Scientific Meeting of the American College of Rheumatology.
UCB, which is developing the drug with US-based partner Immunomedics, says all epratuzumab doses had numerically superior response rates compared to placebo at week 12.
For patients receiving epratuzumab at a cumulative dose of 2400mg, there were “meaningful and statistically significant” reductions in SLE disease activity – double those of placebo.
There was a similar incidence of serious adverse events, including infections, and infusion reactions compared to placebo.
“Given these positive results, we remain excited at the future potential of epratuzumab,” Wallace added.
EMBLEM follows two previous phase II randomized controlled trials, in which results were also promising.
It is the latest movement of note in this therapy area: in August, GlaxoSmithKline and Human Genome Science’s Benlysta (belimumab) was given priority review status in SLE by US regulator the FDA.
Adam Hill
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