Lupus Research Institute Encouraged by Phase 2 Trial Results of Experimental Drug Epratuzumab

The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Immunomedics and UCB on the successful results of the Phase 2b clinical trial of epratuzumab for people with systemic lupus.

“It is heartening to see success in lupus trials and to see innovative companies investing in new research to combat this devastating disease,” said LRI President, Margaret G. Dowd. “Lupus is full of surprises and this is a welcome outcome. Each successful trial brings us closer to a cure and we look forward to the results of the next trial phase.”

In the mid-stage trial, there was a favorable difference in reduction of lupus symptoms between the placebo group and at least one treatment group detected early (12 weeks) after the start of treatment at different dosage levels.

“We all hope that this therapy moves to the next phase of clinical development and that it continues to show promise,” said Betty Diamond, MD, chief of the Autoimmune Disease Center at the Feinstein Institute for Medical Research at North Shore-LIJ Health System upon hearing the results. “We celebrate continued interest in clinical trials in lupus.”

Although its exact mechanism of action is unknown, epratuzumab likely works to reduce lupus symptoms by acting as an inhibitor to CD22, a cell surface receptor that when blocked has an indirect effect of inhibiting the activity of the immune system’s B cells, explained Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA and founder of LRI Coalition member Lupus LA.

A previous trial had shown steroid-sparing properties, fewer disease flares, and improvements in patient quality of life,” added Wallace, who was one of the study’s principal investigators. “Now these promising results provide new hope for the millions of people struggling with this difficult disease.”

“Because there is still so much about this complex and surprising disease that we don’t understand,” said Dowd, “it's critical to explore multiple research areas and to stay open to the best new ideas. We need to encourage scientists to think creatively, take risks and bring new ideas, new questions and new sets of eyes to bear on the complexities of lupus and autoimmmunity.”

“Finding a cure will require corporations, government, and private funders, like the LRI, to pioneer new approaches in lupus research,” she said.