UCB Announces Epratuzumab Fails to Meet Primary Efficacy Endpoint In SLE Phase 3 Trials

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by Ines Martins, PhD |

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According to a recent press release from UCB, a global biopharma company, results from its Phase 3 clinical trials in patients with systemic lupus erythematosus (SLE) revealed that Epratuzumab did not meet its primary efficacy endpoint.

A total of 786  and 788 patients with SLE took part in the EMBOBY 1 and EMBODY 2 clinical trials, respectively. In addition to standard treatment with glucocorticoids and other regular therapy regimens, including immunosuppressants or antimalarial therapy, patients received 600 mg of epratuzumab every week for a period of 4 weeks, 1,200 mg every 2 weeks for a period of 4 weeks, or a placebo.

“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 a 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, licensed by UCB from Immunomedics, is a humanized antibody which targets CD22, an antigen found on the surface of B-lymphocytes (white blood cells critical for an efficient immune response). Elevated expression of CD22 and other B-cell receptor-associated(BCR)proteins on B-lymphocytes has been associated with systemic lupus erythematosus, chronic autoimmune diseases, and certain types of cancers.

According to the release there were no safety concerns in both trials. The most frequent adverse events included urinary tract infections, headache, upper respiratory tract infections, and nausea in both trials.

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