The first patient has been dosed in a Phase 2 clinical trial of KD025, Kadmon Corp’s rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, for the treatment of idiopathic pulmonary fibrosis (IPF), according to a company news release.
The randomized, open-label, 24-week study examines the safety, tolerability and activity of KD025 in IPF patients in the United States who have received or been offered pirfenidone and/or nintedanib. Thirty-six patients will be randomized into two cohorts: one cohort of 24 patients treated with KD025 at 400 mg QD, versus another cohort of 12 patients treated with standard of care.
In fibrotic diseases like IPF, ROCK2 signaling is up-regulated in fibrotic tissues, effecting macrophage infiltration, endothelial cell activation and myofibroblast differentiation. These processes result in excess collagen deposition, scar tissue formation, organ malfunction and death. Preclinical research conducted by Kadmon has demonstrated that ROCK2 inhibition has the potential to halt and reverse these fibrotic processes. ROCK2 inhibition with KD025 significantly reduced established lung fibrosis and inflammation and improved pulmonary function in a dose-dependent manner in a bleomycin-induced mouse IPF model.
“This study marks Kadmon’s entry into the field of fibrosis, a disease area where we believe ROCK2 inhibition represents a promising new therapeutic approach,” said Harlan W. Waksal, MD, president and CEO at Kadmon. “Based on our preclinical studies demonstrating the potential anti-fibrotic effects of KD025, we believe our drug may have clinical utility in IPF, a significant unmet medical need.”