Corbus completes patient enrollment in phase 2 trial of Resunab to treat diffuse cutaneous systemic sclerosis

The Company expects to report top-line results from this study in the fourth quarter of 2016.

Principal Investigator Robert Spiera, M.D., Director of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City, commented, "We have long recognized the need for proven therapies for systemic sclerosis and were eager to participate in this clinical study of Resunab. Our hope is that treatment utilizing Resunab will lead to a reduction of inflammation and fibrosis without immunosuppression and without the need for patients to discontinue their other medications."

Corbus launched its Phase 2 clinical study of Resunab for the treatment of systemic sclerosis in August 2015. The multi-center, double-blind, randomized, placebo-control Phase 2 study is being conducted in the United States, and is designed to evaluate Resunab’s efficacy, safety and tolerability in up to 44 individuals with systemic sclerosis.

Efficacy is measured using the American College of Rheumatology’s Combined Response Index for diffuse cutaneous Systemic Sclerosis (CRISS) which includes measurements of skin and lung involvement, patient disability, and patient and physician assessments of general health.

This Phase 2 study is also evaluating multiple secondary endpoints, including Resunab’s mechanism of action and effect on biomarkers in systemic sclerosis. Subjects in the study are treated with Resunab or placebo for 84 days with a follow-up period of 28 days.

"We are very pleased to have completed patient enrollment ahead of schedule in this Phase 2 study in systemic sclerosis. These patients suffer from serious morbidity and have a significant need for new effective treatments, especially those that don’t suppress the immune system. We look forward to having the top-line data before the end of this year. Additionally, we will be collecting data on safety and efficacy of Resunab in systemic sclerosis in the open-label extension phase of this study," stated Barbara White, M.D., Chief Medical Officer of Corbus.

Yuval Cohen, Ph.D., Chief Executive Officer of Corbus commented, "We are very pleased to have accomplished this clinical milestone for Corbus and are looking forward to completing the treatment phase of this study and releasing top-line data in the fourth quarter this year. We are grateful to the individuals, their families and physicians who are participating in the studies."

Resunab was granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis from the U.S. Food and Drug Administration ("FDA") in 2015. Corbus received approval for an open-label extension to its Phase 2 Clinical Study of Resunab for systemic sclerosis from the FDA in April of 2016.

The open-label extension enables all the participants in the study to receive Resunab for an additional 12 months.