Corbus Pharmaceuticals Announces First Patient Dosed in Phase 2 Study of Resunab for Systemic Sclerosis

Corbus Pharmaceuticals Holdings, Inc.

announced today that the first subject was dosed in the Phase 2 clinical study of its investigational new drug Resunab™ for the treatment of diffuse cutaneous systemic sclerosis ("systemic sclerosis"). Resunab was granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis from the U.S. Food and Drug Administration earlier this year. 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, "Our patients recognize the unmet need for better therapies for systemic sclerosis, and are very receptive to participating in this careful early phase clinical trial aimed at evaluating the safety and potential efficacy of Resunab in treating this often devastating disease." The multi-center, double-blind, randomized, placebo-control trial is being conducted in the United States and is designed to evaluate Resunab's safety and tolerability in up to 36 individuals with systemic sclerosis. In addition, the impact on clinical outcomes will be measured using the Combined Response Index for diffuse cutaneous Systemic Sclerosis. Subjects in the study will be treated for 84 days with a follow-up period of 28 days. The Phase 2 study will also evaluate multiple secondary endpoints, including Resunab's effect on patient-reported outcomes, as well as Resunab's mechanism of action and effect on biomarkers in systemic sclerosis. For more information on the Phase 2 study with Resunab for the treatment of systemic sclerosis, please visit ClinicalTrials.gov and reference Identifier NCT02465437. "People with systemic sclerosis face serious and sometimes life-threatening health issues. We believe Resunab offers these people the opportunity to improve the course of their disease in a way never tested before. As a CB2 agonist, Resunab has the potential to be a disease-modifying agent in systemic sclerosis, by resolving inflammation and stopping further fibrosis, without immunosuppression," commented Barbara White, M.D., Chief Medical Officer of the Company.