FDA Grants Orphan Drug Designation to Kadmon’s KD025 for the Treatment of cGVHD
Kadmon Holdings, Inc. (KDMN)
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Source: Business Wire
NEW YORK--(BUSINESS WIRE)-- Kadmon Holdings, Inc. (NYSE: KDMN) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to KD025, the Company’s Rho-associated coiled-coil kinase (ROCK) inhibitor, for the treatment of chronic graft-versus-host disease (cGVHD), a serious complication following allogeneic bone marrow or stem cell transplantation. KD025 is being studied in an ongoing Phase 2 clinical trial in adults with steroid-dependent or steroid-refractory cGVHD and active disease. The dose-finding study includes 48 patients divided into three cohorts at different dose levels (KD025 200 mg QD, 200 mg BID and 400 mg QD), enrolled sequentially following a safety assessment of each cohort. As previously reported, in a preliminary analysis of data from the lowest-dose cohort (n=17), KD025 200 mg QD demonstrated clinically meaningful responses, with no drug-related
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