Posted by Michael Wonder on 18 Oct 2018
FDA grants breakthrough therapy designation to Kadmon's KD025 for chronic graft-versus-host disease
17 October 2018 - Kadmon Holdings today announced that the U.S. FDA has granted breakthrough therapy designation to KD025, the company’s ROCK2 inhibitor, for the treatment of patients with chronic graft-versus-host disease after failure of two or more lines of systemic therapy.
Kadmon is currently enrolling patients in a pivotal Phase 2 clinical trial of KD025 in patients with cGVHD.
The breakthrough therapy designation of KD025 in cGVHD is supported by data from an ongoing Phase 2 clinical trial (KD025-208). In the study, KD025 was well tolerated and demonstrated clinical activity in approximately two-thirds of patients across Cohort 1 (KD025 200 mg QD) and Cohort 2 (KD025 200 mg BID). Preliminary results from the trial were previously presented at the 23rd Congress of the European Haematology Association in June 2018 and at the Blood and Marrow Transplantation Tandem Meetings in February 2018.
