| 2018-10-17 09:23:35|
KDMN 09:23 10/17 10/17/18
Kadmon announces FDA breakthrough therapy designation granted to KD025
Kadmon announced that the FDA has granted breakthrough therapy designation to KD025, the company's ROCK2 inhibitor, for the treatment of patients with chronic graft-versus-host disease, or cGVHD, 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 designation of KD025 in cGVHD is supported by data from an ongoing Phase 2 clinical trial. In the study, KD025 was well tolerated and demonstrated clinical activity in approximately two-thirds of patients across Cohort 1 and Cohort 2. Preliminary results from the trial were previously presented at the 23rd Congress of the European Hematology Association, or EHA in June and at the Blood and Marrow Transplantation, or BMT meetings. Enrollment is ongoing in KD025-213, the pivotal Phase 2 clinical trial of KD025 in adults with cGVHD who have received at least two prior lines of systemic therapy. KD025-213 is an open-label trial in which patients are randomized to receive either KD025 200 mg QD or 200 mg BID, enrolling 63 patients per arm. Either KD025 dose may be considered by the FDA for the registrational dose.