KD025 has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with chronic graft-versus-host disease (cGvHD) after failure of two or more lines of systemic therapy.
KD025, a Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, binds to and inhibits the serine/threonine kinase activity of ROCK2 thus blocks the signaling pathway which plays major roles in pro- and anti-inflammatory immune responses. The FDA granted orphan drug designation to KD025 for the treatment of cGvHD in October 2017.
This decision by the FDA was based on data from an ongoing phase II, dose-escalation, open-label study (KD025-208), which is evaluating the safety, tolerability, and activity of KD025 in patients with cGvHD. Preliminary results from the study were presented at the 23rd Congress of the European Hematology Association (EHA) in June 2018; and at 44th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in March 2018.
- GLOBE Newswire: FDA Grants Breakthrough Therapy Designation to Kadmon's KD025 for Chronic Graft-Versus-Host Disease. 2018 Oct 17. https://globenewswire.com/news-release/2018/10/17/1622724/0/en/FDA-Grants-Breakthrough-Therapy-Designation-to-Kadmon-s-KD025-for-Chronic-Graft-Versus-Host-Disease.html [Accessed 2018 Oct 18]
- Jagasia M. et al. A phase 2 open-label trial of KD025-208 for steroid-dependent chronic graft-versus-host disease (cGvHD). 23rd Congress of the European Hematology Association (EHA) in June 2018; 44th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in March 2018.