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Catalyst Info & Data Links
TITLE: Belumosudil (KD025) for Chronic Graft versus Host Disease (cGVHD)
ClinicalTrials.gov (NCT02841995) A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
2020: Presentation and Management of cGVHD in Real-World Clinical Practice: A Medical Chart Audit. European Hematology Association.
2020: Interim Analysis of KD025-213: A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Chronic Graft Versus Host Disease (cGVHD) after at Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study; NCT03640481). TCT| Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR. TCT Meetings.
2020: KD025 for Patients with Chronic Graft-Versus-Host Disease (cGVHD)–Long-Term Follow-up of a Phase 2a Study (KD025-208). Biology of Blood and Marrow Transplantation, 26(3), S187-S188.
MECHANISM OF ACTION
KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. In addition to cGVHD, KD025 is being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209). KD025 was granted Breakthrough Therapy Designation and Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with cGVHD who have received at least two prior lines of systemic therapy.
cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and gastrointestinal tract. Approximately 14,000 patients in the United States are currently living with cGVHD, and approximately 5,000 new patients are diagnosed with cGVHD per year.
Updated by HC
#KDMN, #Chronic Graft versus Host Disease, #cGVHD, #Belumosudil, #KD025, #Selective ROCK2 inhibitor, #immune response, #immunity, #transplant, #donor bone marrow, #stem cells
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