UCB has announced that the two EMBODY™ Phase 3 clinical studies for epratuzumab in Systemic Lupus Erythematosus (SLE) did not meet their primary clinical efficacy endpoints in either dose in both studies. Treatment response in patients who received epratuzumab in addition to standard therapy was not statistically significantly higher than those who received placebo in addition to standard therapy.1
"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. We would like to express our sincere thanks to the patients and clinical investigators who made the EMBODY™ program possible. It has produced a comprehensive dataset and we look forward to sharing the findings with the scientific community," said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB. "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."
The EMBODY™ Phase 3 clinical program consisted of two identical studies - EMBODY™ 1 and EMBODY™ 2. EMBODY™ 1 and EMBODY™ 2 were multicenter, randomized, double-blind, placebo-controlled 48-week studies. In each study, patients (n= 786 for EMBODY™ 1; n=788 for EMBODY™ 2) received placebo or treatment with 2400 mg of epratuzumab over four 12-week treatment cycles, administered as 600 mg every week for four weeks or 1,200 mg every two weeks for four weeks. All patients were taking corticosteroids at the start of the trial, in addition to epratuzumab or placebo, while immunosuppressant and antimalarial therapies were administered per their standard therapy regimen. The primary endpoint of the studies was the percentage of patients meeting treatment response criteria at Week 48 according to a combined response index, the BILAG-based Combined Lupus Assessment (BICLA).1
A high level review of the safety data did not identify any new safety concerns. The most common adverse events in both studies were upper respiratory tract infection, urinary tract infection, headache and nausea.
Epratuzumab is an investigational medicine and is not approved for the treatment of SLE by any regulatory authority worldwide. Epratuzumab was licensed from Immunomedics Inc (NASDAQ: IMMU) by UCB for clinical development and commercialization in all autoimmune disorders.
Epratuzumab is a monoclonal antibody to target CD22, a protein that modulates B-cells, which are key components of the immune system and can play a central role in the pathogenesis of SLE if they become overactive. While the mechanism of action of epratuzumab is not fully elucidated, data indicate that it binds to CD22, resulting in diminished SLE-related hyperactivity of B cells without depleting them.2