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UCB announces epratuzumab fails to meet endpoint in phase 3 SLE trials
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Epratuzumab did not meet its primary efficacy endpoint in two phase 3 trials in patients with systemic lupus erythematosus, according to a press release from UCB.
The trials included 786 patients with systemic lupus erythematosus (SLE) in the EMBODY 1 trial and 788 patients with SLE in the EMBODY 2 trial who received placebo, 600 mg of epratuzumab weekly for 4 weeks or 1,200 mg every 2 weeks for 4 weeks in addition to regular treatment with glucocorticoids and other standard therapy regimens, including antimalarial therapy or immunosuppressants.
“Although we are disappointed with the results from the phase 3 program, our commitment to the lupus community remains. We are focused on developing new therapies for the treatment of immunological conditions, including SLE, and have another SLE drug in clinical development,” Iris Loew-Friedrich, MD, PhD, chief medical officer and executive vice president of UCB, said in the release. “Today’s news does not alter UCB’s strategy as we remain committed to delivering value for patients living with lupus and other immunologic diseases.”
Epratuzumab is a monoclonal antibody designed to target the B cell-modulating CD-22 protein licensed by UCB from Immunomedics.
No new safety concerns arose from the safety data in the studies, according to the release. Common adverse events included upper respiratory tract infections, urinary tract infections, headache and nausea in both trials.
Reference : www.ucb.com.