Belumosudil in Systemic Sclerosis

Systemic Sclerosis (SSc) is a chronic immune disorder characterized by fibrosis of the skin and internal organs. Currently, there are no FDA-approved targeted therapies for SSc, which affects 75,000 to 100,000 people in the United States[2]. Belumosudil, Kadmon’s ROCK2 inhibitor, has demonstrated activity in preclinical sclerodermatous models. Enrollment is ongoing in a randomized, placebo-controlled, Phase 2 clinical trial of belumosudil (KD025-209) in 60 patients with diffuse cutaneous SSc. Enrollment is also ongoing in an open-label, Phase 2 clinical trial of belumosudil (KD025-215) in up to 15 patients with diffuse cutaneous SSc. Initial data from this study are expected by year-end 2021.

[2] American College of Rheumatology. “Largest study evaluating survival in systemic sclerosis patients following lung transplantation.” Press release, November 16, 2014.