UCB (EURONEXT: UCB) and U.S. based partner Immunomedics Inc. (NASDAQ: IMMU) today announced the enrollment of the first patient into EMBODY™, one of two pivotal phase III studies of epratuzumab in patients with moderate to severe systemic lupus erythematosus (SLE).
Patient enrollment for EMBODY™ has also begun.
“We are pleased to announce the launch of our phase III programme with epratuzumab which marks UCB’s intent to develop this compound for such a severe disease,” said Prof. Dr. Iris Loew-Friedrich, Chief Medical Officer of UCB.
She added, “The consistency of improvements demonstrated by epratuzumab in the clinical studies to date is an encouraging platform to start the next phase of trials, and is a hopeful sign of the drug’s potential to become an effective new treatment option for lupus.”
Both studies (EMBODY™ and EMBODY™) are multicenter, placebo-controlled, randomized, double-blind studies designed to evaluate the efficacy, safety, tolerability, and immunogenicity of epratuzumab in patients with moderate to severe SLE.
Each study will last a maximum of 54 weeks and will randomize 780 patients in the study, with approximately 130 planned investigational sites per study.
The phase III programme has undergone the relevant regulatory advice procedures.
The primary objective of the studies is to confirm the clinical efficacy of epratuzumab in the treatment of patients with moderate to severe general SLE, in addition to continuing standard of care treatments.
The results from the phase IIb study, EMBLEM™, showed that all epratuzumab doses, which ranged from 200mg to 3,600mg cumulative dose administered during one 12-week treatment cycle had numerically superior response rates compared to placebo at week 12.
For patients receiving epratuzumab at a cumulative dose of 2,400mg there were meaningful and statistically significant* reductions in SLE disease activity, with responder rates more than double those of placebo.
The EMBLEM™ results showed that in a patient population with predominantly high disease activity, epratuzumab improved patients’ health at week 12, with the emergence of improvements as early as week 8.
Epratuzumab was associated with a similar incidence of serious adverse events (including infections) and infusion reactions compared to placebo.
* This study was not powered to detect statistical differences between treatment arms (p values were not adjusted for multiple comparisons and are based on an exploratory post-hoc analysis)