Two Phase 3 clinical trials for epratuzumab in Systemic Lupus Erythematosus (SLE) did not meet primary endpoint, pharmaceutical UCB has announced.
The two EMBODY Phase 3 clinical studies for epratuzumab in 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.
The EMBODY Phase 3 clinical program consisted of two identical studies – EMBODY 1 and EMBODY 2. They were both multi-centre, randomised, 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 2,400mg of epratuzumab over four 12-week treatment cycles, administered as 600mg every week for four weeks or 1,200mg 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).
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 by UCB for clinical development and commercialization in all autoimmune disorders.
Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB, said: “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.
“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.”
SLE, also known as lupus, is a chronic autoimmune disease which can affect multiple organ systems including the skin, joints, kidneys, brain, blood, heart and lungs. Common symptoms include fatigue, fever, joint pain, skin lesions and chest pain. Patients often develop a characteristic butterfly-shaped rash across their cheeks and nose. Additional symptoms may be present depending on the organs affected. Patients usually experience alternating periods of remission—during which disease activity is low and symptoms may ease—and periods of high disease activity known as flares, when symptoms worsen. During flares, the immune system attacks healthy tissue causing inflammation that can lead to organ damage.
It is estimated that 5 million people throughout the world have SLE, the majority of whom are women aged 15-44.