The Phase 2 study (KD025-215) will enroll up to 15 adults with dcSSc who will receive orally administered belumosudil 200 mg twice daily (BID). The primary endpoint is the Combined Response Index for Systemic Sclerosis (CRISS) score. The Company plans to present initial data from this study by year-end 2021.
In addition to the KD025-215 trial, an ongoing, double-blind, placebo-controlled Phase 2 clinical trial of belumosudil (KD025-209) is currently enrolling 60 adults with dcSSc. Patients are randomized to receive belumosudil 200 mg once daily (QD), belumosudil 200 mg BID or placebo.
"As we await the results of our placebo-controlled study, we are pleased to concurrently initiate the open-label trial of belumosudil in systemic sclerosis, as its mechanism represents a promising therapeutic approach for this difficult-to-treat disease," said
Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and pro-fibrotic processes. The FDA granted Priority Review for the New Drug Application (NDA) for belumosudil for the treatment of chronic graft-versus-host disease (cGVHD) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of
Kadmon is a clinical-stage biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. Kadmon's clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies.
Forward Looking Statements
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