Kadmon (KDMN) Commences Dosing in KD025 Phase 2

September 21, 2016 4:05 PM EDT
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Kadmon Holdings, Inc. (NYSE: KDMN) announced that the first patient has been dosed in a Phase 2 clinical trial of KD025, the Company’s rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, for the treatment of chronic graft-versus-host disease (cGVHD). The randomized, open-label, 24-week study examines the safety, tolerability and activity of KD025 dosed at 200 mg once daily (QD), 200 mg twice daily (BID) or 400 mg QD in 48 cGVHD patients in the United States.

cGVHD is a common and often fatal complication following allogeneic stem cell transplantation in which donor immune cells attack the recipient’s body, leading to fibrosis in multiple organs. Preclinical research conducted by Kadmon in collaboration with Bruce Blazar, MD, of the University of Minnesota and recently published in the journal Blood demonstrated that ROCK2 inhibition with KD025 down-regulated clinical symptoms in multiple murine models of cGVHD. KD025 treatment also down-regulated the pro-inflammatory signaling pathways involved in cGVHD pathogenesis and simultaneously up-regulated regulatory cell function in these murine models, reducing overall cGVHD progression while preserving normal immune function.

“Kadmon’s preclinical research has demonstrated the potential of ROCK2 inhibition to treat a number of autoimmune and fibrotic diseases, including cGVHD, a serious condition with limited treatment options,” said Harlan W. Waksal, M.D., President and Chief Executive Officer of Kadmon. “In this Phase 2 study, we hope to further assess the ability of KD025, our lead ROCK2 inhibitor, to ameliorate the cGVHD process.”

In addition to cGVHD, Kadmon is investigating the potential of KD025 to treat other autoimmune and fibrotic diseases. The company is conducting an ongoing Phase 2 clinical study of KD025 for the treatment of idiopathic pulmonary fibrosis, with a planned Phase 2 study in moderate to severe psoriasis.

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