Corbus Pharmaceuticals Holdings Inc. on Monday announced that patient enrollment has commenced in the Phase 2 clinical study of its investigational new drug, Resunab, designed for the treatment of diffuse cutaneous systemic sclerosis.
"The launch of this study is an important milestone in the clinical development of Resunab,” Barbara White, chief medical officer of Corbus, said. “More importantly, Resunab has the potential to provide an entirely new approach to treat people with systemic sclerosis, who clearly need effective therapies without adversely suppressing their immune system."
Systemic sclerosis is a life-threatening autoimmune disease characterized by chronic activation of the immune system, damage to blood vessels and fibrosis of the skin, lungs and other internal organs.
The study is being led by principal investigator Robert Spiera, director of the vasculitis and scleroderma program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City.
"Resunab has anti-inflammatory and anti-fibrotic effects that are so relevant to the disease process in systemic sclerosis,” Spiera said. “We are hopeful that Resunab has the potential to address the significant unmet need for effective treatments that improve skin and lung involvement and other disease manifestations in people with this devastating disease. Currently, there are limited treatments for these patients, and the mechanism of action of Resunab through induction of SPMs has the potential to provide clinical benefit to them."